38 Burst results for "FDA"

Fresh update on "fda" discussed on WTOP 24 Hour News

WTOP 24 Hour News

00:33 min | 5 hrs ago

Fresh update on "fda" discussed on WTOP 24 Hour News

"Something that they've always wanted to do Gigi Barnett WTP news Benzene a known cancer causing chemical was found in more than half of 108 batches of antiperspirant and deodorant body sprays from 30 different brands This according to a citizen's petition filed with the FDA this month the FDA did allow a temporary use of benzene and liquid hand sanitizers during the pandemic but it says it shouldn't be used in the manufacture of drug substances Last week out of an abundance of caution Procter & Gamble voluntarily pulled 17 types of old spice and secret antiperspirant off the shelves a number of other brands have yet not yet been recalled New findings about the health of the Chesapeake bays dead zone where oysters crabs and fish struggled to survive Beth McGee with the Chesapeake Bay foundation explains what the dead zone is The area in the bay and many of its tidal rivers that during the summer does not have enough oxygen to support aquatic life This year the Chesapeake Bay program partners teams of Maryland Virginia federal agencies and academic institutions found that the dead zone was average in size striking finding climate change is making the dead zone worse At the same time officials cooperating in the bay program are also working on ways to achieve the goal of cutting the pollutants that generate dead zones Kate Ryan W TOP news Up ahead here on WTO P will check sports and then police in Frederick Maryland investigate the possible drugging of a woman at a sports bar 1113 The following is a paid commercial message Superheroes are usually fictional characters like Superman and Wonder Woman But at vehicles for change our superheroes are real people like you Individuals with a.

Gigi Barnett FDA Chesapeake Bays Beth Mcgee Procter & Gamble Chesapeake Bay Foundation Cancer Chesapeake Bay Kate Ryan Maryland Virginia WTO Frederick
Pfizer seeks US booster OK for kids aged 16-17

AP News Radio

00:41 sec | 17 hrs ago

Pfizer seeks US booster OK for kids aged 16-17

"With with new new concerns concerns about about coded coded nineteen nineteen Pfizer's Pfizer's asking asking federal federal regulators regulators for for permission permission to to give give booster booster shots shots to to older older teens teens right right now now U. U. S. S. health health authorities authorities are are recommending recommending Kobe Kobe booster booster shots shots for for all all adults adults eighteen eighteen and and up up and and warn warn it's it's especially especially urgent urgent now now with with the the Omicron Omicron very very introspective introspective being being even even more more contagious contagious than than the the delta delta variant variant visor visor C. C. E. E. O. O. says says they've they've reached reached out out to to the the FDA FDA asking asking regulators regulators to to allow allow booster booster shots shots for for sixteen sixteen and and seventeen seventeen year year olds olds to to offer offer them them extra extra protection protection the the food food and and drug drug administration administration is is expected expected to to consider consider the the request request rapidly rapidly I'm I'm Jackie Jackie Quinn Quinn

Pfizer Kobe Kobe C. C. E. E. O. O. FDA Food Food And And Drug Drug Ad Jackie Jackie Quinn Quinn
Fresh update on "fda" discussed on Jim Bohannon

Jim Bohannon

01:11 min | 11 hrs ago

Fresh update on "fda" discussed on Jim Bohannon

"Pill for Merck and ridgeback biotherapeutics called mono peera vere the drug could possibly become the very first antiviral pill under emergency use authorization to treat COVID-19 in the U.S. Significant unmet medical need exists for safe and effective Therapeutics for COVID-19 That's Merck senior vice president a doctor Sean Curtis speaking to a Food and Drug Administration advisory panel Many Americans remain at high risk for infection severe illness and death According to Merck the latest research indicates mono peer reviewer reduced hospitalizations and deaths by 30% among adults infected with the coronavirus but the effectiveness dropped significantly by 20% compared to results released earlier Mark vice president doctor dariya huzur says despite those findings the pill did well in trials and will likely perform well against any new variants Lonely pair of your treatment led to a more rapid decline in infectious virus Studies also indicate there may be some risks to pregnant and childbearing women according to FDA research officer Mark seton And malformation of the eye kidney and axial skeleton in rat fetuses suggested monopoly may cause fetal harm with administered to pregnant individuals FDA adviser doctor James hildreth also offered his take before the committee He voted against emergency use authorization of the field I think the general toxicity data there are more questions than answers The drug is already authorized for emergency use in the UK Officials say it could be authorized in the United States in days and available by the end of the year In Washington I'm Kathy foster Our number one 8 6 6 5 O Jimbo one 8 6 6 5 O 5 four 6 two 6 certainly the word panic at this stage should not be applied to all of this We simply don't know enough to panic I suppose that you could say some of the steps being taken are efforts in the direction of a prudent policy And if that proves to be an overreaction then you can always dial it back That would certainly be a possibility but again we don't have a magic wand to know precisely what this omega crown variant can and will do Nor are we obviously totally happy with the Merck pill that has been brought forward although other than the fact that pregnant women will clearly not be advised to getting it well we'll proceed based on that rather narrow 13 to ten vote for approval in this country and before that in the United Kingdom So your thoughts about where we are as we seem to be heading into another era of shutdowns lockdowns mass the whole routine One 8 6 6 5 O Jimbo one 8 6 6 5 O 5 four 6 two 6 is our number and will continue with more on the Jimbo.

Merck Ridgeback Biotherapeutics Covid Sean Curtis FDA Mark Vice President Doctor Dar Mark Seton James Hildreth Kathy Foster United States United Kingdom Washington
FDA: Merck COVID pill effective, experts will review safety

AP News Radio

00:48 sec | 5 d ago

FDA: Merck COVID pill effective, experts will review safety

"U. S. health officials say Merck's experimental cope with nineteen pill is effective but the raising questions about its safety during pregnancy I'm Ben Thomas with some details the food and drug administration posted its review ahead of a public meeting next week what outside experts will debate the drug's benefits and risks FDA scientists identified several potential risks including possible toxicity and birth defects they also note mark collected far less safety data overall that has been gathered for other covert nineteen therapies all covered nineteen drugs currently authorized by the FDA require an injection or IV which limits their use if authorized Merck's drug would be the first pill treatment that patients could take it home it's already authorized for emergency use in the U. K. I'm Ben Thomas

Food And Drug Administration Ben Thomas Merck U.
Fresh update on "fda" discussed on WTOP 24 Hour News

WTOP 24 Hour News

00:48 min | 12 hrs ago

Fresh update on "fda" discussed on WTOP 24 Hour News

"Week voted to recommend emergency authorization of Merck's pill to treat COVID But it was a close vote in the N 13 to ten to be exact The recommendation coming after hours of debate about the drugs modest benefits and potential safety issues Katherine Ellen foley covers the FDA for Politico This pill is designed to interrupt the way that the SARS CoV-2 virus replicates So it stops the virus from replicating And to do that it sort of causes the virus's genetic material to be full of mutations So eventually it just dies out Who this drug is for was hotly debated in Merck's study They looked at individuals who were adults so at least over 18 and had at least one or more morbidity one or more condition that put them at a high risk of developing severe COVID-19 and individuals who were unvaccinated So these were folks who either were living with diabetes or were obese or had other risk factors that made them more likely to go into the hospital And they also weren't vaccinated previously So the advisory committee was really unsure about who should get this drug if it should be people who fall under the CDC's definition of being at a high risk of developing severe COVID or if it should be only people who are unvaccinated and also at a high risk like the people included in Merck's study And there's a whole other discussion about people who are pregnant which we can get into if you want Obviously that would be one of the concerns that the advisory panel had since ten out of the 23 people on this committee voted against it Talk about the concerns for pregnant women and maybe some other medical concerns here So there weren't any pregnant people included in Merck's study And they typically don't do that because we want to make sure that we're protecting people who are pregnant who are at higher risk of developing all sorts of things in clinical trials But in this case what they did instead was look at animal models And in some animal models it looked like this antiviral was causing birth defects or miscarriages And so even though we haven't seen those effects in people thank goodness A lot of these physicians and scientists were really concerned about what might happen if pregnant people were to take this drug So there was a lot of discussion about whether or not pregnant people should be able to access this drug at all or if it should be only in certain circumstances when their healthcare providers believe that the benefit greatly outweighs the risk And then there were also some questions about whether or not it matters what stage of pregnancy someone is in and also whether it matters if someone is nursing or not So all of these questions were really kind of left open ended And we don't really have great data on that just yet What happens from this point going forward with authorizing this pill for people to actually use Yeah so the FDA now can choose whether it wants to agree with its independent advisory committee and work through the final labeling for the drug or they can disagree with it Typically the agency sides with its independent advisory committee but it doesn't have to Let it go reporter Katherine Ellen foley who covers the Food and Drug Administration talking there with Brennan and Shawn You are listening to 103.5 FM at WT dot com At Doctors Without Borders we believe the best medical care knows no boundaries We responded to the pandemic around the world including right here in the United States Because.

Merck Katherine Ellen Foley Sars FDA CDC Diabetes Brennan Shawn United States
US opens COVID boosters to all adults, urges them for 50+

AP News Radio

00:46 sec | Last week

US opens COVID boosters to all adults, urges them for 50+

"Hi Mike Rossi a reporting cobit boosters are approved for all adults in the United States the food and drug administration has authorized extra shots of Fizer at the dirt a covert nineteen vaccines for all adults the FDA is also urging people fifty and older to get a booster to ward off the winter search the FDA action came after months of debate among experts over whether everyone eighteen and older should get an extra shot for protection in September the FDA's old advisers rejected boosters for all the dolls authorizing the extra shots only for those sixty five and older or those at high risk because of health problems their jobs or living conditions but the White House continued to press for broader use and nearly a dozen states had recently authorized boosters for all adults Mike Rossi at Washington

FDA Mike Rossi Fizer United States White House Washington
US advisers support expanding COVID boosters to all adults

AP News Radio

00:56 sec | Last week

US advisers support expanding COVID boosters to all adults

"The government has moved to open cove it nineteen booster shots to all adults as experts worry a steady rise in virus cases could lead to a holiday season search the FDA says anyone eighteen and over can pick either replies or or matured a booster six months after their last dose about a dozen states were already offering the shots on their own amid complaints the federal regulations on who could get them work too confusing we heard loud and clear that people needed something simpler and this I think is simple hours after FDA vaccine chief Peter marks talk to the AP CDC advisers like Dr Camille Nelson cotton agreed all American can understand the track teams that are recommended for them at that time the CDC advisers went even further stressing people fifty and over should get a booster Sager mag ani Washington

FDA Peter Marks Dr Camille Nelson Cotton Government CDC Ani Washington
US expands COVID boosters to all adults, final hurdle ahead

AP News Radio

00:47 sec | Last week

US expands COVID boosters to all adults, final hurdle ahead

"Federal regulators are expanding cold it nineteen booster shots to all adults the one hurdle remains Pfizer and the door to say the FDA has signed off on making boosters available to everyone eighteen and older simplifying what has been a confusing list of who's eligible but there's still one more step the CDC has to agree that even healthy young adults should get I the replies were made during a booster the agency's advisors will discuss later today if the CDC or proves as well tens of millions more Americans could have three doses before the new year as a rise in virus cases could get worse with the holidays anyone who received a single dose of Johnson and Johnson vaccine is already eligible for a booster Sager make ani Washington

CDC Pfizer FDA Johnson Sager Ani Washington
Pfizer, U.S. ink $5.29B deal for possible COVID-19 treatment

AP News Radio

00:36 sec | Last week

Pfizer, U.S. ink $5.29B deal for possible COVID-19 treatment

"While Fizer waits for federal regulators to approve its experimental cope with nineteen treatment hill it's ready to sell millions of courses to the government files arrest the FDA this week to authorize the potential treatment which has been shown to significantly cut hospitalizations and deaths among infected people if regulators approve the pale the governments agreed to buy ten million treatment courses for about five hundred twenty nine dollars each it already had a deal to pay roughly seven hundred dollars each for courses of Merck's competing pill which the FDA is now reviewing Sager made Ghani Washington

Fizer FDA Government Merck Sager Ghani Washington
Pfizer asks US officials to OK promising COVID-19 pill

AP News Radio

00:47 sec | 2 weeks ago

Pfizer asks US officials to OK promising COVID-19 pill

"Fizer is asking federal regulators to authorize its experimental cope with nineteen kills the drug is among a handful of pills recently shown to significantly cut hospitalizations and deaths among infected people if the FDA signs off it could be a major step toward managing the pandemic offering an easy and effective home treatment all authorize treatments now require an IV or injection at a hospital or clinic the FDA is already set this month to discuss a competing drug from Merck Pfizer's filing comes as covert nineteen infections are again rising at the U. S. mainly driven by a hot spots in states where colder weather is pushing people indoors Sager mag ani Washington

Fizer FDA Merck Pfizer U. Washington
Florida woman who sued for ivermectin dies from COVID

AP News Radio

00:47 sec | 2 weeks ago

Florida woman who sued for ivermectin dies from COVID

"A Florida teacher hospitalised with cove it has died after her husband tried but failed to force doctors to treat her with ivermectin tomorrow drop was forty seven years old she died twelve weeks after being admitted to Palm Beach gardens Medical Center her husband Ryan sued the hospital last month trying to get doctors to give ivermectin that's a drug used to treat conditions caused by parasitic worms the FDA has not approved ivermectin to treat cove it and Ryan dropped lost its court battle the judge saying allowing judges to counter man doctors decisions could set a dangerous precedent Ryan drug says he's not giving up telling the Palm Beach post I'm hoping the name a law after her he said so no one has to go through this I'm Rita folate

Palm Beach Gardens Medical Cen Ryan Florida FDA Palm Beach Post Rita Folate
More turn to abortion pills by mail, with legality uncertain

AP News Radio

01:04 min | 2 weeks ago

More turn to abortion pills by mail, with legality uncertain

"Earlier this year the blighted ministration lifted an FDA ban against allowing the mail delivery of abortion pills because of the pandemic but some states are considering laws to make that illegal a ban on the delivery of abortion pills takes effect next month in Texas south Dakota's governor bandit by executive order and a handful of other states are working on legislation for women seeking to end a pregnancy it is confusing says Utah OBGYN doctor me ship had gas a patchwork of laws that are criminalizing women are pregnant people speaking to self manage their own portion she says it's safe and women don't necessarily need to see a doctor to use an abortion pill comparing it to a miscarriage that occurs at home the group Susan B. Anthony list once a doctor involved policy director Susan Swayze lie down a model bill would look like it would require an in person exam roughly forty percent of the abortions in the U. S. are done through medication hi Jackie Quinn

FDA South Dakota Texas Utah Susan Swayze Susan B. Anthony U. Jackie Quinn
Biden picks ex-FDA chief Robert Califf to again lead agency

AP News Radio

00:48 sec | 2 weeks ago

Biden picks ex-FDA chief Robert Califf to again lead agency

"President Biden has picked an old hand to again lead the food and drug administration the president's nominee the doctor Robert Calif for FDA commissioner a post he held in the Obama administration's final year the agency's been without a permanent chief for months the president says it's mission critical to have a steady hand guiding the FDA as it deals with cold in nineteen backseat authorization and all other issues noting Calif is a leading clinical trial specialist but his first into the FDA was dominated by controversies including surging opioid addiction West Virginia senator Joe Manchin says keyless nomination is an insult to families in his state whose lives have been ravaged by addiction and says he will not vote for Calif Sager or may god he at the White House

Food And Drug Administration President Biden Robert Calif Obama Administration Senator Joe Manchin Calif West Virginia Calif Sager White House
 Biden picks ex-FDA chief Robert Califf to again lead agency

AP News Radio

00:34 sec | 2 weeks ago

Biden picks ex-FDA chief Robert Califf to again lead agency

"President Biden is tapping a familiar name to head the food and drug administration Robert Calif was the FDA's chief at the Obama administrations and and a person familiar with the decision says the president's naming him to reprise the role now caliphs nomination comes amid months of concern that an agency near the center of the federal code nineteen response does not have a prominent leader Janet woodcock's been acting commissioner for ten months if the Senate confirms same Calif would oversee not just FDA decisions on Kobe Bryant team vaccines but

President Biden Robert Calif Obama Administrations FDA Janet Woodcock Calif Senate Kobe Bryant
Colorado governor says all adults can get COVID booster shot

AP News Radio

00:47 sec | 2 weeks ago

Colorado governor says all adults can get COVID booster shot

"Hi Mike Rossi a reporting Colorado's governor says all adults can get a cove it nineteen booster shot with corona virus infection surging in his state Colorado governor Jared Polish defied federal guidance Thursday and issued an order allowing all state residents eighteen and older to get cold it nineteen booster shots the U. S. food and drug administration allows booster shots for those eighteen and over who are at high risk of exposure to the virus adults with special medical conditions and all people sixty five and older the bite that ministration had envisioned boosters for all adults but in September FDA scientific advisers rejected extra Fizer doses for everyone on Tuesday Beiser asked U. S. regulators to allow boosters of its covert nineteen vaccine for anyone eighteen and older hi Mike Crossey up

Mike Rossi Jared Polish Colorado U. S. Food And Drug Administra Fizer Beiser FDA Mike Crossey
Pfizer asks FDA to OK COVID-19 booster shots for all adults

AP News Radio

00:46 sec | 3 weeks ago

Pfizer asks FDA to OK COVID-19 booster shots for all adults

"Fizer is asking the food and drug administration to approve cope with nineteen vaccine booster shots for all adults the FDA's advisers in September voted against authorizing extra Fizer doses for everyone eighteen and over saying they weren't convinced the younger healthy people need another shot but BAFTA itself said he'd would move fast to expand boosters if needed advisers offering early results of a study showing the three doses effectiveness under today's policies about two of every three vaccinated adults is expected to qualify for a booster within a few months many who don't qualify you can still get one because most providers don't check if they're eligible Sagarin make ani Washington

Fizer Food And Drug Administration Bafta Sagarin Ani Washington
Update on the latest sports

AP News Radio

00:59 min | 3 weeks ago

Update on the latest sports

"AP sports I'm guessing Kaulbach Packers quarterback Aaron Rodgers says he sought alternative treatments instead of the NFL endorsed covert nineteen vaccinations Rogers told SiriusXM's Pat McAfee show Friday that he opted against the two main FDA approved shots because he is allergic to an unspecified ingredient the reigning NFL MVP learned he had tested positive for Colbert nineteen on Wednesday and will be away from the team for ten days including missing Sunday's game at Kansas city the Browns are cutting ties with former all pro wide receiver Odell Beckham junior Cleveland announced Friday it planned to grant the disgruntled twenty nine year old former first round pick his release after a tumultuous two and a half seasons dusty Baker is returning to manage the Astros for a third season after agreeing to a one year contract the seventy two year old Baker became the first manager in major league history to lead five different teams to the postseason as Houston fell to the Atlanta Braves in six games in this year's World Series yes in Coolbaugh AP sports

Kaulbach Packers Pat Mcafee NFL Aaron Rodgers Siriusxm Odell Beckham AP Rogers Colbert FDA Browns Kansas City Baker Cleveland Astros Atlanta Braves Houston
Pfizer says COVID-19 pill cut hospital, death risk by 90%

AP News Radio

00:52 sec | 3 weeks ago

Pfizer says COVID-19 pill cut hospital, death risk by 90%

"Pfizer is touting an experimental cope with nineteen treatment it says he is strongly effective Fizer science chief Michael Goldstine says the anti viral peel cut hospitalization and death rates by nearly ninety percent of high risk adults with cove in nineteen a better showing than even he predicted it's just extraordinary I feel that's the position on so I'm positive so I missed the visor is part of the race to find an easy to use strong for treating the corona viruses since most treatments now require an IV or injection with tens of millions of adults still unvaccinated such drugs will be critical for curbing future waves the FDA is already reviewing competitor Merck's covert nineteen killed the United Kingdom yesterday became the first nation to approve it Sager mag ani Washington

Michael Goldstine Pfizer FDA Merck United Kingdom Ani Washington
New COVID-19 pill cut hospital, death risk by 90%

AP News Radio

00:43 sec | 3 weeks ago

New COVID-19 pill cut hospital, death risk by 90%

"Pfizer is joining the race to bring easy to use covert nineteen medication to the U. S. market the drug maker says its experimental antiviral pill cuts rates of hospitalization and death by nearly ninety percent Pfizer plans to ask the food and drug administration and the international regulators to authorize it as soon as possible after Fizer applies the FDA could make a decision within weeks or months the FDA already is reviewing Merck's cobit nineteen pill on Thursday the United Kingdom became the first country to okay it currently all cobit nineteen treatments used in the U. S. require an IV or injection my camp in Washington

Fizer FDA U. Merck United Kingdom Washington
 EXPLAINER: What to know about vaccines for kids aged 5-11

AP News Radio

00:42 sec | Last month

EXPLAINER: What to know about vaccines for kids aged 5-11

"As federal vaccine advisers prepare to give their final approval the by the administration says it's quickly shipping millions of Pfizer's covert nineteen doses nationwide for use in kids the FDA has already cleared shots for those ages five to eleven tomorrow the CDC's advisors will discuss more detailed recommendations and in the meantime we are not waiting on the operations and logistics White House virus response chief Jeff Zion says millions of doses are already headed to doctors offices and other sites he says there are enough shots on hand for all twenty eight million kids five to eleven range the first shots could be administered this week Sager

Pfizer Jeff Zion FDA CDC White House Sager
Is the COVID-19 vaccine safe for children?

AP News Radio

00:50 sec | Last month

Is the COVID-19 vaccine safe for children?

"The food and drug administration has determined child sized doses of Pfizer's Kopet nineteen vaccine are safe and effective for younger children hi Ben Thomas with a look at the potential side effects that were examined the FDA assess the vaccine safety in thirty one hundred youngsters and found they had similar or fewer reactions than older people largely sore arms are aching us but one very rare side effect that has shown up in teens and young adults through intense scrutiny myocarditis or heart inflammation those affected have been mostly young men and teenage boys usually after the second dose and they have tended to recover quickly experts note covert nineteen itself also causes heart information often more severe U. S. health officials concluded for five to eleven year olds the vaccine's benefits outweighed that small risk I'm Ben Thomas

FDA Ben Thomas Pfizer Heart Inflammation
"fda" Discussed on The Model Health Show

The Model Health Show

05:30 min | 2 months ago

"fda" Discussed on The Model Health Show

"The payment like we want company xs product to get approved. Because it's going to help to increase our market share is well and increase our exposure. So this is all happening. This is called post hack contribution so this is after the fact so it's not like they're giving the money right then and there to make the approval. There's like you know what we'll wait a little while you go ahead approve. This will wait a little bit. Nobody would notice. We'll give something later. Let's make this happen. Could be to the tune of tens of thousands hundreds of thousands. They're even some instances where these physicians received over a million dollars. It's available these things song so it sounds like a movie of corruption and deceit. But it's real so think about the drugs that are getting put. Onto the market the drugs that are getting mandated for people to take. Where's the efficacy really at. Are we doing stuff. The right way because in reality. We're seeing that when a drug is approved and it's marketed to the public and used by the public so over four years later when that first safety event is being acknowledged. We don't know what's going to happen. And i encourage you. I implore you to take more precautions and to be more patient with this than ever before regardless of the pressure regardless of what the media or the pharmaceutical companies are well meaning physicians in advocates. Who truly do want to do the right thing. Where do you think. They're getting their information from their getting educated by these same entities that are ripe with corruption and manipulation consistently criminal organizations. This brings us to the point of the fda with these. Well noted well documented again this was published in the journal. Science forty percent physician advised on the fda approval boards receiving payments from pharmaceutical companies. At some point after they approved a drug. This is called bribery. This is.

fda the journal
"fda" Discussed on The Model Health Show

The Model Health Show

05:31 min | 2 months ago

"fda" Discussed on The Model Health Show

"Drugs or the third or fourth leading cause of death in our society. It's funny you don't hear more about that. And it has a lot to do again with who's tracking things behind the scenes in propping that up when you go and check out. What are the top ten caused the death. You're not gonna see that unless you know where to look because it's true. It's absolutely true pharmaceutical drugs. He'll hundreds of thousands of americans every year. You have the right to know about it now. You would think that the all powerful fda would crackdown on pharmaceutical companies. Crackdown on all of these deadly incidents to protect us citizens but then you'd be failing to realize that. Today pharmaceutical companies provide the fda with nearly half of their overall budget and upwards of seventy five percent of its scientific review. Budget of the fda itself is coming from those same form sue companies that it's supposed to be regulating. In fact pharmaceutical companies provide billions of dollars in funding to the fda every year. The very organisation responsible for regulating. Drug companies is massively funded by those same drug companies. The question is houses happening. Well it began with the advent of something called user fees under the guise of providing the fda with more resources to approve drugs and get them to the market for patients who may need them. Faster legislation was passed put in place to allow drug companies to begin paying the fda directly hefty user fees with a guarantee date of review to be completed for them. So they're gonna pay these massive fees the fda fast review and a guaranteed date on when they're going to get to their approval again. These user fees are the magnitude of billions of dollars collectively from pharmaceutical companies packets to the. Fda's coffers an analysis that was published in the journal of law medicine ethics titled institutional corruption pharmaceuticals and the myth of safe and effective drugs states quote the authorization of user fees in nineteen ninety-two has turned drug. Companies into the fda's prime clients deepening. The regulatory and cultural capture.

fda journal of law medicine
"fda" Discussed on The Model Health Show

The Model Health Show

04:54 min | 2 months ago

"fda" Discussed on The Model Health Show

"Approved by the fda had some kind of safety event after reaching the market. Nearly one third. Now what's most alarming about. All of this is the timeline of these safety. Events being noticed and being acknowledged the average time from approval of the drug getting to market and the first post market safety event was four point two years later four point two years after the drug is deemed to be safe in allow to be marketed to our citizens now in this analysis again published by the journal of the american medical association. The fda was right about drug safety about sixty nine percent of the time if we were to use the analogy of our education system for example the fda would be a d. student. I now that's okay. If millions of lives weren't routinely destroyed because of the d. student level success rate. That will be okay if they didn't receive billions of dollars in funding each year to ensure that they were above a d. level student to ensure that they are actually doing things with high efficacy but the receiving this funding under the is that having this supreme influence and supreme control is needed in order for them to be the best of the best in the world. But if you actually look at the success rate is far from what people are led to believe again. The median time the average time from the drug being approved as safe then allowed to be marketed and consumed by the public the average time from getting released and being approved to the first acknowledged safety. Event is an average of four point two years later years later now with this being the case unfortunately there have been very well educated and well intentioned people who've naively believed that the recent drugs that have been approved by the fda that if there was a big problem that it would be seen within the first few weeks or the first few months when in reality most of the safety events are seen years later and is just as if this is lost in this conversation and overlooking how biology really works. We don't know all the ramifications of a new drug intervention that quickly. That's just not how biology works now in an attempt to excuse the poor performance seen in this fda analysis david gardner a former fda officials.

fda journal of the american medica david gardner
"fda" Discussed on The Model Health Show

The Model Health Show

01:51 min | 2 months ago

"fda" Discussed on The Model Health Show

"Cosmetic act established new drug regulations including pre market approval of all new drugs meaning that drug companies had to prove that their drug was safe before could be sold to the public. Prior to this people's just put stuff out on. The streets would stuff on store shelves without a lot of regulation in so this really brought to bear and again this wasn't that long ago was nineteen thirty eight when this transformation took place of fda grew in power immensely in the preceding years through legislation through government influence in one thousand nine hundred sixty for example drugmakers. Tried to get the sedative. The little approved in the us as it had been approved already in several other countries but the fda blocked it calling for further safety studies to be done on its use and as it turned out the little meyde actually caused thousands of birth defects. The fda's decision to plate safe and to call for further testing saved lives and helped to solidify the fda as a leading regulatory agency. Now all of these things sound pretty great but things have changed dramatically in recent years. The fda was once an organization that was exclusively funded by taxpayers and thus working for our citizens today however the fda is substantially funded by pharmaceutical companies themselves to the tune of billions of dollars each year. Now to find out how he got from there to here and what the results have been because of it. We must take a deep dive into the world of this regulatory agency the fda the food and drug administration. Now you might think that a drug receiving.

fda us
"fda" Discussed on The Last American Vagabond

The Last American Vagabond

02:15 min | 3 months ago

"fda" Discussed on The Last American Vagabond

"As well from you know compromise these are all things that just happened so that emergency uses don't affect again understand unjustified on emergency use in my opinion that shouldn't be allowed as or as well with the approval of my opinion now goes on to say that then says the comedy which is the new name there the official name. That's why they're saying that. Because this is one that's been approved is. Fda approved may by pfizer. It is approved as two dose series prevent cobra nineteen sixteen years of aging older. See i know this is. I think this is meant to be confusing. Now it says they also the fda approved this and the e the emergency was author. That stupid it says the emergency use authorization authorized pfizer vaccine have the same formulation and can be used interchangeably. Now that's the point that they have one that says emergency authorizing label. That can still give that to somebody. Who's there for the approved. a sixteen knows. And that's what they're arguing. None of this. I agree with by the way. But i but this is not. It is approved a sixteen and older according to their data. Which i disagree should be happening. But here's the main point. That i think a lot of people. Independent media are don't understand this says in this at the bottom of that same document. What is emergencies authorization. I've read you this many times. One of the main factors here is about what if once it's approved the emerged. The authorisation just disappears in regard to that specific section of the approval. It's still the emergency authorization in general is still in effect member. That's where we renewed every ninety days by the government by the. Hhs we keep pointing that out. I forget where we are right now and that ninety day process sure will cut back on that a second as it goes closer. That applies anything. They've used that for math. These are all sorts of things. Then you've got these specific emergency use authorization for the injections specifically each one right now. Once they approve any any section of that sixteen and older whatever. That is that improved. And that's no longer the authorized but the emergency authorization is still in effect for twelve and older and for the general country now says this emergency use authorization for pfizer biotech kobe. Nineteen injection or comedy will end when the sector secretary of hhs determines that over which is so arbitrary. Get to pick when they decided to over or when there is a change in the approval status.

pfizer Fda fda hhs
"fda" Discussed on Ron Paul Liberty Report

Ron Paul Liberty Report

05:15 min | 3 months ago

"fda" Discussed on Ron Paul Liberty Report

"But there it's going to be sold as this is the final stamp of approval. The fda is god. god almighty has spoken. And if you don't get a job then you're against god and the science but we know that the fda's record of approving drugs. It's not all that great. You know anyone who's had some problems solidified problems. You can go down the list of drugs that have been approved of actually had to be rescinded So it's not as set in stone as one might think or certainly as mainstream media might want to portray but the thing that we do know. Is that everyone who every american who wants to have a shot has either got it or can easily get it without a problem. So what does it mean to have the fool. Fda approval before for twelve and above actually twelve and under that. Still under emergency use at this point but what does it mean. It means i think the doors open now for vaccine mandates. He's going to be get the shot or get out of work was interesting that we see. Dr paul is that's running up against something else which is fundamental labor shortage. And i know this is anecdotal. But i've seen several things where a company a small company would say. Listen guys you need to get your shot or you're going to get fired and they all got together and said okay. We're leaving and they changed the rules. I've seen that several times on twitter over the weekend and again that's anecdotal but it's going to be interesting. How those two are going to square and example of what you just described Is what happened in houston methodist hospital There were people should take no how what's going on. If the people who were involved in participating you know to to an extreme in helping people who had covert nurses and the aides who were exposed and they come up with a conclusion. I don't want to shot you. Think you'd think they would at least be recognized. Why are you doing this. They must have a perception so They they were fired as laid off temporarily. But they were out of there. Now you hear the the The advertisements going all across the country To find nursing shortage so we all this thing about a lot of jobs available and no Nobody available nobody wants to work. It is so different than if you're in a depression and People there are jobs no jobs available now the head jobs available you find people. Only government could create a situation like bank to on this fda and the approval of this drug on what will happen if you make the point that You know the ball you know. The final opinion is is not yet. It's going to be determined..

fda Dr paul houston methodist hospital Fda twitter depression
"fda" Discussed on Slate's If Then

Slate's If Then

04:49 min | 3 months ago

"fda" Discussed on Slate's If Then

"Who are still holding out on vaccines as we're taping this episode. The fda is expected to give emergency authorization for booster shots for immuno-compromised people at any moment. But sarah has reported that some folks in the biden administration. Worry that the need for boosters might feed fears of the vaccines are ineffective and slow down vaccination rates the administration has left walking a tight rope eagerly awaiting approval being very careful not to appear to be pressuring the fda and right now the agency doesn't even have a permanent boss someone to fight it's public battles in washington one thing that definitely people inside the fda and former fda officials want to see is a permanent commissioner. So right now there's an acting. Commissioner president biden has not named a permanent person to the post and while the acting. Commissioner janet woodcock has been there for decades on his very experienced. I think that there is this general desire that someone on top of the agency can really B- it's be as mascot beat the person on the on the airwaves on television. Who can say. Here's what to expect about an fda vaccine approval. Here's how we did it To have that public face that right now is basically falling on on fouts. She who people bradley trust. But he's not the head of the fda no and indeed fouts has been out there saying gee. I hope they do this soon. I hope i don't predict that. I hope that it will be within the next few weeks. I hope it's within the month of august. If that's the case. Yeah i guess. I wonder how the lack of a permanent head kind of plays into all of this. Like is it as you're saying that there's no one out there to be a cheerleader and explain what the agency does or does that have organizational ramifications internally. Fda is a massive place never really sort of well oiled machine so the vaccine department is headed up by a man called. Peter marks who has while trusted well respected Even among or i should say regardless of political party. He worked closely with the trump administration and now with the biden administration so in terms of the vaccine decisions. It doesn't actually matter who's on top of the agency. And i know that sounds weird but i think it's more about these lingering confidence questions and kind of the public facing aspects of this in the story that you wrote. You had sources telling you that you know people in the administration were frustrated by how slow this process was but of course if you as an administration as the biden administration has done come out and say we believe in science. We want science to lead the way you have to let the science have the time to to breathe. How how do the various players involved strike a balance here. it's hard i mean You talk to foul. she will. He'll talk on on television but he also he'll tell reporters individually that he's not saying he wants them to approve it soon. He's saying he hopes they'll prove it soon. But he's still saying it and you know it is very delicate. Play that they have here. The events of last year is still hang heavy over. Fda the idea that president trump was openly pressuring the agency and that the biden administration feels in the way that it's been described to me that they want to make sure that they are showing people that are leading with science and not trying to leave the scientists in so while they want this they are also conditioning. It on when fda's ready there's a sentence From the new york times columnist. Michelle goldberg that. That really stuck with me. She wrote about kids and and getting emergency use authorization for kids. And she's writing about the fda and she wrote at some point too much institutional risk aversion is a risk itself. And it it like it somehow nailed. How complicated all of this is because yes it science but that sentences like oh wait. Maybe this is politics. I see exactly where she is coming from there. I think the opposite is equally damaging though that if you move too quickly on something You could be paying for that for years in. So what is so interesting though about that. Sentiment is kind of already in motion. The fda has learned a.

biden administration fda fouts Commissioner president biden Commissioner janet woodcock sarah Fda bradley washington president trump Peter Michelle goldberg new york times
"fda" Discussed on Slate's If Then

Slate's If Then

07:55 min | 3 months ago

"fda" Discussed on Slate's If Then

"How can you help. Ensure our future is filled with trees by choosing paper and paper packaging because when you buy products made from this natural renewable resource you encourage forest owners to plant and grow trees for generations to come in the united states family and privately owned forest lands provide most of the wood and fiber used to make all kinds of essential items like the paper paper packaging. You come on every day. These forest owners care for their land and the trees on it with sustainability in mind working to keep both healthy and thriving over the decades. Sustainable forestry has continued to evolve encompassing all of the ways the paper industry helps forests stay vital and productive from preserving wildlife habitats to protecting water sources to preventing soil erosion learn more about the benefits that paper and packaging create for our forests at paper for nature dot com choose paper and paper packaging and be a force four nature. This podcast is supported by. At and t. active armor right now. Our lives are on our phones. I use mine to schedule. Podcast guests read the news and video. Call my family. There's no room for fraud calls thankfully. At and t. Makes customer security a priority helping block those pesky calls. It's not complicated. At and t. Active armor twenty four seven proactive network security and fraud call blocking to help stop threats at no extra charge. Compatible device or service required visit att dot com slash active armor for details. This is what next tvd. i'm lizzie. O'leary and i'm talking with political reporter sara over m- all right now. The fda feels a little bit like a watched pot public. Health officials are anxiously hoping for full approval of the three cova vaccines and at the same time. They and a lot of parents are waiting on what the agency has to say about vaccines for kids. And what the clinical trials for those pediatric vaccines show. What do we know about the the trials for kids. I mean i'm the mother of a one year old. I want him vaccinated yesterday. But you know like any person who i think. Trust and independent agency or believes in the independence of agencies. I want them to have looked at all of of the data. And i do feel like that kind of encapsulates where they are. Where a lot of a lot of people are so. Where are we in those trials. What we know about them is that there are a lot smaller than the adult trials. Where the adults for each manufacturer. They had to enroll at least thirty thousand adults. These trials actually are only a few thousand kids and the reason for that is. It's it's hard to enroll kids in special very very young children. I mean they are going down to as young as six months old. We know that did are expected. In the fall. probably visor madonna. I because they started trials earliest in that also. The trials are ongoing in in several countries does approving the vaccines for adult use full approval delay at all emergencies authorization for kids or are they totally separate tracks. It does not delay at all but the tracks could merge there are real questions right now within fda and even within the the vaccine manufacturers about whether they would apply for emergency use in children reason for that being emergency use has to be something done because the benefits far outweigh any sort of risk in not that they think that it's risky to children but severe cove. Nineteen is less risky to children than it is to adults in so it is possible especially if they've already got the foundation of adults and teenagers being approved for this that they might wait out. Emergency use authorization for children. It's a really hard sell to tell parents of a six-year-old. Hey this is emergency use authorized. Your child needs to get it. There's this policy discussion about whether it's better to just go to approve with those and that is not a definitive. That is ongoing. They are still talking about what what that will look like. So we don't know yet whether someone like my child who's the youngest batch out there would maybe get an emergency use authorization or whether we'll skip straight to full approval for him. Yeah we don't know there's also the idea that you have some large employers mandating vaccines the military doing it. You know how how much does full approval matter in making employers comfortable with mandates and maybe making employees comfortable with those mandates. I think it's sad. And that's one of the reasons why biden officials have been so keen for fda to approve as fast as possible. President biden did say that he wants every federal worker to be vaccinated or to undergo routine testing. But that doesn't apply to the department of defense they have to have it actually be approved or else they're definitely gonna face legal battles from from armed service members who say why am i required to get something that's not approved and be there has to be a safety argument for it that we need you to have this for your own safety that that one's an easier argument to make then there are the other people who aren't vaccinated yet those who twelve and older who just chosen not to get their shots and there's some evidence that full. Fda approval might nudge some of them toward the shot in opole from the kaiser family foundation roughly thirty percent of unvaccinated. People said they'd be more likely to get a fully approved vaccine rather than one with an emergency use authorization. I wonder if you think. Full approval might really sway people or if it's a sort of a proxy for discomfort with the whole process. Kaiser actually touched on this in that poll because they said that while thirty percent of people said that when they asked respondents is it approved authorized. Two-thirds thought it already was approved. And so there's a general public lack of understanding about this process. I don't blame people. It's it's a regulatory process that few people have had to understand before this pandemic. But i think you're totally right that this could be kind of a proxy for general safety concerns or general hesitations in that. There's going to have to be much more dialogue to get people on board with. Yeah i i you know i hear you describe this regulatory process that does sound quite thorough because the fda was specific and making it through. And yet i think the word emergency still trips people. Yeah it's it's not a sound particularly nice phrase emergency authorization in it. It does imply the urgency that we have had around this and now. We've all been living with these vaccinations and we know that largely You know about things have not happened or when they have the blood clots. You know the other reactions. We now have a better understanding of them. I think another part of the challenge there though is is not just that all of us who got vaccinated are fine but this idea of whether these vaccines are gonna be around for years and years the specter of of boosters And how that could also play into confidence questions for people.

fda leary lizzie President biden sara united states madonna opole biden department of defense kaiser family foundation Fda Kaiser
"fda" Discussed on Slate's If Then

Slate's If Then

02:19 min | 3 months ago

"fda" Discussed on Slate's If Then

"Are inspectors looking at facilities that is vital because The consistency of vaccines is is crucial. Obviously thinking you don't want your vaccine to be slightly different than the one that you're you know brother sister friend guy in so just as they are asking all the companies about you know. The data in different populations who was enrolled in clinical trials. They are doing on site visits to factories. Batch testing different batches that come off the production line to make sure they're exactly like each other and you know looking at at the hygiene safety etc. That's one of the reasons. Actually one of the major reasons. That's another vaccine. Astrazeneca hasn't even bothered filing for authorisation yet in in might not even file for approval. They haven't gotten those production questions sorted out and so that is just as important to the fda as analyzing the clinical trial data. I feel like in the past few weeks. The demands for the fda to grant full approval to these kobe. Vaccines have gotten a lot louder. I guess it kind of want to explore the reasons why with you and why it matters you wrote a story saying the fda is expected to approve the pfizer vaccine by early september and that people within the fda were working around the clock. And i have to admit. I read it and thought wait a minute. We're they already working around the clock fair. Hey i even thought that i mean it is. It is typical that it takes this amount of time for a vaccine or new medicine to be approved. Fda actually bylaws is required to review new drugs and vaccines in a certain amount of time and they have not reached that time limit with these vaccines. But you're right in in questioning why there wouldn't be twenty.

fda Astrazeneca pfizer Fda
"fda" Discussed on Slate's If Then

Slate's If Then

07:46 min | 3 months ago

"fda" Discussed on Slate's If Then

"How can you help ensure our futures filled with trees by choosing paper and paper packaging because when you buy products made from this natural renewable resource you encourage forest owners to plant and grow trees for generations to come in the united states family and privately owned forest lands provide most of the wood and fiber used to make all kinds of essential items like with paper and paper packaging. You count on every day. These forest owners care for their land and the trees on it with sustainability in mind working to keep both healthy and thriving over the decades. Sustainable forestry has continued to evolve encompassing all of the ways the paper industry helps forestay vital and productive from preserving wildlife habitats to protecting water sources to preventing soil erosion learn more about the benefits that paper and packaging create for our forests at paper for nature dot com choose paper and paper packaging and be a force for nature toward the end of last year. An important group of doctors started meeting online the vaccines and related biological products advisory committee into mouthful. The group evaluates vaccines and advises the fda. The agency doesn't have to do what these doctors recommend. But it often does are like you add my welcome to this one hundred sixty second meeting vaccine related biological advisory committee of the fda last year. The committee started looking at the cova. Vaccines beginning with pfizer. We have one cat at of us today and that is to discuss and vote on the emergency use authorization of the pfizer buying check ovid nineteen vaccine for the prevent the whole thing and the public record. If you listen to their meetings you can hear the doctors ask the company representatives all sorts of questions about the vaccines mechanisms reactions. Who was included in clinical trials. Thank you dr manteo. My question is provider and it relates to the recruitment of minorities into the study. My understanding is that the minorities were recruited fairly late in the process. Do we have an adequate Follow up to the to that group compared to the majority of participants at the end of the big meetings. There were three one for each vaccine. The panel voted in favor of emergency. Use authorizations they said the benefits of these vaccines outweigh the risks shortly thereafter. The fda granted the eu. As sarah over mall. Watch this all. Play out could you lay out kind of the relationship between that. Advisory committee the fda and the various authorizations. How does that picture fit together. The advisory committees have played an important role for the fda for years. They're a group of outside experts in the case of this vaccine committee. A lot of virologist vaccine experts and pediatricians in also people from different agencies. they'll have representatives from fda from cdc from the nih what they didn't kind of lay out the concerns that can be had about vaccines in a way where they ask questions about you know. Have you had enough data from pregnant women. Have you had enough data from ultra elderly people people who are above the age of eighty or ninety. Why are there not enough non white people in this trial when this panel is asking questions. Do you ever get hints about things. They or the agency might wanna see as a vaccine moves toward full approval after that. Emergency use authorization totally. Yeah yeah that's one really valuable thing about these panels outside experts don't have to Be as diplomatic may be government officials. Dues they will variously say you know you are missing information about this and i wanna see this so in the months between those committee meetings out of the authorization and the approvals that we could have within the next few weeks or months. Those companies have been working on answers for those questions in a more complete picture of what their vaccine does. And who doesn't foreign. How well it does it for different populations nine months after those i e you as the data overwhelmingly suggests the vaccines are safe. And effective and recent data published in the new england journal of medicine says full amarna vaccination is about eighty eight percent effective at preventing symptomatic kovin with the delta variant. But those questions that the advisory committee asked about pregnant women minority populations and various rare side effects. The answers to those questions will dictate how soon the vaccine's clear the next big regulatory hurdle full approval. The whole idea here is that when fda approved something. They're putting their stamp on it saying this is safe and effective its benefits absolutely do way its risks and also we know what those risks are. So if you're a call this feels like a century ago but when the pfizer vaccine rolled out there were reports of serious allergic reactions that we're not seeing in the early data that was submitted for the authorisation. Once you roll something out to the broader population you are going to get a bigger picture of how a vaccine works or doesn't work or what risks happen. The ideas that with approval. They know what those lists are for a wide range of people per exactly they have more data. They have tens of thousands of people that they've been tracking for months and months and so they're heading higher bar than they did for the authorisation. And ideally all those questions answered you know. I think a lot of people are maybe bluntly wondering what's taking the fda so long is is not a fair question to ask. It is especially when you know. People have only just recently gotten familiar. With how the vaccine development process works like. Yeah what what is taking up the ace along and the answer said it generally does take them months to approve something. Of course you would expect that with covet vaccine. It'd be a lot of urgency. And i think that there is but what they're doing in those months between authorization and eventual approval is going through all these raw data for tens of thousands of people. So where the emergency use authorization depended on fifteen thousand people. Overall trials had to be thirty thousand people in you'll get people enrolled with any range of medical issues people across the board on age People with any other. You know socioeconomic factors that can play into this People with different jobs where they could be highly exposed. It's about enrolling all those people than handing on that information to fema and they have to go through all of that all those thousands of pages about those thousands of people and so that's ultimately why it's taking this long. What else goes into the process that we might not think about. I didn't know for example that you know there.

fda pfizer dr manteo Advisory committee nih united states cdc eu sarah new england journal of medicin fema
"fda" Discussed on Slate's If Then

Slate's If Then

01:37 min | 3 months ago

"fda" Discussed on Slate's If Then

"Toward the end of last year. An important group of doctors started meeting online the vaccines and related biological products advisory committee into mouthful. The group evaluates vaccines and advises the fda. The agency doesn't have to do what these doctors recommend. But it often does are like you add my welcome to this one hundred sixty second meeting vaccine related biological advisory committee of the fda last year. The committee started looking at the cova. Vaccines beginning with pfizer. We have one cat at of us today and that is to discuss and vote on the emergency use authorization of the pfizer buying check ovid nineteen vaccine for the prevent the whole thing and the public record. If you listen to their meetings you can hear the doctors ask the company representatives all sorts of questions about the vaccines mechanisms reactions. Who was included in clinical trials. Thank you dr manteo. My question is provider and it relates to the recruitment of minorities into the study. My understanding is that the minorities were recruited fairly late in the process. Do we have an adequate Follow up to the to that group compared to the majority of participants at the end of the big meetings. There were three one for each vaccine. The panel voted in favor of emergency. Use authorizations they said the benefits of these vaccines outweigh the risks shortly thereafter. The fda granted the eu.

fda jansen pfizer madonna us
"fda" Discussed on KLBJ 590AM

KLBJ 590AM

05:24 min | 1 year ago

"fda" Discussed on KLBJ 590AM

"Rollie. Good morning, Roy. Hey, how's it going? Fine. Hey, I was calling about the, uh, the vaccine and the FDA. Yes, sir. Yeah, I feel they should go ahead and ship all that stuff and should all be in place and then wait for them to, uh Prove it or somebody should kick him in the butt and get it approved, But it should always should already be in place. Now it is. Yeah, they're getting that's already in place. And here locally in the United States, they're still waiting for FDA approval That could come in a scheduled meeting on December the 10th and maybe another meeting on December the 17th. Meanwhile, the UK has already cleared the way and they'll start giving out vaccines almost immediately. As you know, with the U. S government. Nothing can be done without a meeting or two or 15. Britain's medicines and healthcare products Regulatory Agency recommended visors Corona virus vaccine could be used after its data review showed the vaccine was 95% effective overall and that it also offered significant protection for older people. UK health secretary man, Hancock says hospitals and vaccination centers will take delivery of the vaccines first, and then also be a community rolled out, including GPS and pharmacists. They expect to get there first shipment of 800,000 doses within days and immediately begin giving shots here in the U. S Advisors. Emergency use hearing with the FDA is set for December. 10th On your great powers. Fox News. All right. There you go Jump in here at 51283605 90, so Democrat Texas lawmakers they're going to take into the shot and legalizing marijuana. Here in Texas. The Legislature convenes in January State representative Joe Moody. He's from El Paso and state rap Rolando Gutierrez of San Antonio. They have both already pre filed bills that would likely come up when the session gets underway. But this is far from the first time Texas lawmakers have actually published our push this kind of legalization, A k V reports the Texas House actually passed to build a decriminalize possession in 2019 on lead to have it die in the Texas Senate without a vote. They don't even consider it now. Historically, the state has taken a tough stance on marijuana possession in 1931, the Legislature made possession of any amount of marijuana. Ah, felony offense punishable up to life in prison. But by the time we got to the seventies, Texas marijuana possession laws became less severe. But even today, if you have up to two ounces in Texas, you're committing a Class B misdemeanor punishable up to six months in jail in a $2000 fine. Possession of more than two ounces could mean a year in jail and possession of more than four ounces of felony was still in recent years. Attitudes towards weed at the Statehouse have will have been shifting slightly slightly. It's a long way to go a very long way to go to still face charges for that little amount of pot to go on going all the way to legalizing and we've got a long way to go. I don't have any. I don't have any hope that that's gonna happen any time soon. So unfortunate lot of money were passing up a lot of lots. Millions. Millions millions. Millions were just saying that we don't want it. In 2019, Texas lawmakers, they legalized the cult of his eight the cult of ization of hip industrial hemp that contains less than 80.3% of THC. The bill also legalized possession of small amounts of hip derived from CBD products. Without the need of doctor's approval. You could you could buy that around town. A lot of people buy that kind of thing for their dog, or even for their own personal use to ease pain. I'll like it material, a variety of issues and elements. Well that same year, lawmakers increase the number of qualifying conditions eligible under the state's low THC medical cannabis program by adding terminal cancer, autism, multiple sclerosis and other serious medical conditions. UH, recently arrest of possession in Texas have dropped in 2018. Before the hip was legalized. The Texas law enforcement arrested about 63,000 people for possession. 20 in 2019. They arrested 45,000. So since the pandemic has has hit us and has led to a projected $4.6 billion shortfall in the state budget, some lawmakers say that legal marijuana industry in Texas create tens of thousands of jobs and bring hundreds of millions of dollars in tax revenue. Good Lord, Yeah, we're just leaving it there right there on the table. Staring at it can't touch it. And you know it is far as the effects of it as far as more crime as far as Maura danger on the road, so I really don't know, I I just I don't get a feel based on what's been going on in Colorado and other states. But that would be that big of an issue and I really don't feel maybe I'm wrong and very naive. I don't smoke pot. But my my hunch is we're not gonna have a ton of people that are gonna decide to take it up just because it's legal. I think if you're smoking if you want to smoke pot, you're already doing it. You got plenty of avenues to find it. You're already doing it. Which which kind of, you know falls back on what you said earlier. People are already doing it. Why not make money off? Exactly Exactly. Now I know it's far from being that simple. Listen up business owner Said managers..

Texas marijuana FDA UK Texas Senate Legislature Texas House Fox News United States Rollie. U. S Advisors Britain U. S Rolando Gutierrez State representative Roy El Paso medical cannabis business owner
"fda" Discussed on WTOP

WTOP

03:24 min | 1 year ago

"fda" Discussed on WTOP

"Talk coffee to the FDA food and drug administration has okayed the first corona virus test that allows self swab at home the food and drug administration has approved the first corona virus test that can be performed at home the test comes from LabCorp additionally it will only be available to health care workers and first responders and only under a doctor's orders samples from the test will be shipped to LabCorp for processing in a statement FDA commissioner Steven Hahn says the test was authorized based on data showing it is as safe and accurate as sample collection at a doctor's office hospital or other testing site Mike Crossey up Washington as mori corona virus tests become available in the U. S. how can you tell whether they're legit or not depending upon which one you're looking at all of that the FDA commissioner Steven Hahn was asked about that last evening and he says there are requirements on companies they are required by us to have south self validation in the required fields label that appropriately in their package insert they also said that we're what we're doing is we're working with folks around the country but here at home making Q. S. government at the NCI and CDC to validate some of those tests that have come forward to us so we're actually doing certain independent value validation and in your question is superb in that if someone wants to use a test that's come to market really it's important to read the information that's in the package insert but often in some of those cases it's also important for the independent labs to do the validation also you may have seen reports in the press of labs around the country that have done that we've actually reached out to the many academics and we will be including that information the information that we generate is whether provides complete and doctors are stressing on another front this morning that kids like adults should practice social distancing except with family members so if kids have to go out in public we have expert advice about face covering events mass for children who are well and healthy and over the age of two R. ka and mask sheets of pediatrics for Kaiser Permanente Adrienne collier you can make them using old T. shirts you can use clock that you have laying around the house as for children with chronic medical conditions such as severe persistent asthma cystic fibrosis or are on means suppressant drugs those children should be wearing an N. ninety five mask when they go to the doctor she says that's the only reason they should be in public otherwise collie is the vice for parents and kids practicing safe social distancing get outside and get some fresh air exercise every single day Kristy king WTOP news the gym is closed in sporting events have been canceled now what Hey how about taking a walk walking is one of the few forms of exercise that we can do well ordered to stay at home and its positive effects may be more than you expect the Wall Street journal says walking can help prevent depression clinical studies found regular aerobic exercise is as effective as antidepressants in reducing symptoms of depression and because exercise raises serotonin levels in your brain it boosts your mood and overall sense of well being it can also help you to get a good night of sleep so how much walking do you need well that's up for debate but some experts say twenty to thirty minutes most days of the week Joan Jones WTOP news many medicines used to treat colds and flu contain acetaminophen a pain reliever and fever reducer founded hundreds of over the counter and prescription.

FDA
"fda" Discussed on KLBJ 590AM

KLBJ 590AM

04:26 min | 1 year ago

"fda" Discussed on KLBJ 590AM

"The FDA talking about the possibilities of a may first restart of our economy well he'll have that audio just here in a second but he's he's talking about how that's a good a good talking points it's a good place to start and obviously we're hopeful about that target but I think it's just too early to be able to tell that we see light at the end of the tunnel if you look at the testing where it is right now the strategic approach has been to focus that testing in hot spot areas for strategy moving forward for opening up the country has to take all of those factors into account yeah you got to take into account so you know the number of cases you have how many ventilator so much bad space and how hard your city has been hit by the cold nineteen right so there you go and may be may first it technically doesn't doesn't sound like a long time but but the way this disease has progressed how quickly it's gonna help how much the story changes day by day I think that it's almost three weeks from now that's a that's a long time we could look at a completely different picture in three weeks yeah I'm not saying it's going to be gone by any stretch of the imagination but things are changing rapidly with this from day to day may first may be a great day for Austin Texas but not necessarily for New York City maybe not yeah maybe not know even though they still got the subway is up and running yeah that that's just at the standing to me getting some breaking news here the U. S. sailor on the corona virus stricken navy ship whenever the weather was so controversial that the captain that was fired yeah has now died from complications resulting the the covert nineteen he's the first as a result of that while it's on that ship that's really right yeah there you go that's there so this story just now making news cafe mark Cuban he's all talking about the possibility of a presidential run yeah he says the corona virus pandemic means that's that's possible he's not ruling it out he's not actively exploring it but he's at least thinking about the possibilities of that he's he's headed to that many many years yeah but he says this coronavirus makes everything different maybe he's you know thinking that we need somebody that's better business minded he says possibly in the White House mmhm okay what he's done pretty well business we know that but it is a little late to get the game at this point for him I don't know if you think it is yeah I do I do although there might be you know some kidding me it it he is the very least could be a Democrat nominee well there are a lot of people that they don't have a nominee that's true that's true there are little people a lot of people out there that did do not like the current nominee Joe Biden he he got another accusation against a complaint an official complaint was filed against him sexual harassment late last week he denies it I thought we were supposed to believe the women I mean that's what he told us while you're in the hashtag me too me too thick I believe her lest it affect you I believe her yeah absolutely listen John Roberts at the White House fox news correspondent John Roberts of the White House updating us on the possibilities of a may first reopened today was the day that president trump had hoped that the country would begin to re open but the conditions just weren't there that became apparent a couple weeks ago to be able to do it so now another soft target date has been set this one for me the first five can the country star to re open a little more than two weeks from now yesterday Dr Anthony felt she was conscious but did leave open the possibility listen here we are hoping that at the end of the month we could look around and say okay is there any element here that we can safely and cautiously start pulling back on it so do it it is not yes continue to hunker down there are a number of things that would have to happen between now and may first to begin the process of bringing the economy back online we have to be on the down slope of the so called infection curb mitigation steps would have to be solidly in grain with the American public and there are signs that that is happening if you've been your local grocery store in the last few days you'll know and it would have to be rigorous testing in place in order to identify and trace any new cases the centers for disease control director Dr Robert Redfield earlier this morning the idea is once we re open we want to stay real and then the tools to make that happen or the fundamentals of public health which I mentioned earlier aggressive case recognition isolation.

FDA
"fda" Discussed on News 96.5 WDBO

News 96.5 WDBO

03:46 min | 1 year ago

"fda" Discussed on News 96.5 WDBO

"That the FDA has not approved of it for coronavirus purposes or yeah right now I can't stand better lives for and you know trump card available you know basically it's pretty much a cashier what would be your message to the American public right guard Kyle take anything I don't believe anything don't believe anything yeah I don't know what they're talking about no one said that no one no one wants yeah hi chloroquine phosphate if anything you have laying around contains this year right you from getting coronavirus nobody said that and I I can't I'm still every time I hear that clip of mice okay look I feel bad for the lady I want to fall through they made a very very very very very stupid decision that are reasonable person would not make and the reporter to say Hey listen he did say that well also yeah he's acting like they just had some exactly Laura Quinn bills hanging around and right all right here we go we'll just take these that's not even close to what happened I think as I understand the story was an ingredient in something else that she had well there's a difference between core client and hydroxy clerk on yes there's a difference yeah you there are other ingredients involved and yes that's what Dr oz had talked about and trump had talked about it and that combination had worked in cases Italy they've done some testing but not enough to go through like an FDA approval and that's why thought she said what he said you know it's not enough for real numbers yet you know to give the you know any okay but anecdotally for people at work I had the clip earlier the guy that was the things that saved his life rise in the hospital Miami they Adam on fox and friends and it was interesting because at the end of that segment they asked him what would your message to the American people be aides say this work for me I think you could be a lifesaver for people but again he was in a hospital and talk to a doctor the doctor said I can't give it to you right but I could refer you to the infectious disease doctor right it also said it's diet you know we can't call the secure all the guys that I want to try it anyway the savior yeah he did just go looking around in his garage for something now cash now I I mean it you feel bad I do this happens but Jeez man yes I know I know okay there was one of the things that we needed to get to hear with coronavirus a store in Denmark figured out a way to stop hand sanitizer hoarding I heard about this what a great story this is yes your first bottle is five dollars and seventy five cents you want an additional bottle it'll cost you a hundred forty three dollars okay I don't have to worry about the hoarding no make do with what you got something for somebody else so is that something like with toilet paper you get the regular pack for whatever the cost you want to second pack two hundred S. yeah that's just encouraging rich people to buy all of it I am firmly against this plan just say one more customer you play the part of millennial reporter really well you can turn anything good into something sour that.

FDA
"fda" Discussed on KOMO

KOMO

05:58 min | 1 year ago

"fda" Discussed on KOMO

"FDA approval moving from request to development to approval in record time this innovative approach centred fully on unleashing the power of the private sector focusing on providing convenient testing to hundreds of thousands of Americans within short turnaround times in less than two weeks together we have developed a solution that we believe will meet the future needs testing needs of Americans I understand how difficult this is Ben I was part of the HIV aids response in the eighties we knew from dying from first finding cases in nineteen eighty one it took us to almost nineteen eighty five to have a test it took us another eleven years to have effective therapy it is because of the lessons learned from that that we were able to mobilize and bring those individuals that were key to the HIV response to this response I understand that a lot of this behind the scenes action over the last couple of weeks was invisible to the press and the American people but this intense effort has not only resulted in innovative solutions but an automated high throughput six system bringing the availability of these quality coronavirus testing to the American people at unprecedented speed finally I want you to know in South Korea they did have a large number of tests available over the last several weeks positivity rate is between three and four percent with lab core request expanded testing their positivity rate is between one and two percent so we want to also announce this new approach to testing which will start in the screening website I'm here this illustrated by Google where clients and patients and people that interest can go fill out a screening questionnaire moved down first symptoms or risk factors yes they would move down this and be told where the drive thru options would be for them to receive this test the labs will then move to the high throughput automated machines to be able to provide results in twenty four to thirty six hours that is the intent of this approach we've seen it work just in our own United States and we want to bring this across the continent thank you very much thank you right I'd like to maybe have Tony you want to come up you become a I think everybody out here knows you pretty well but Tony's been doing a tremendous job working long long hours and you've seen a lot happened but this is been it's been a great experience in working with you has been terrific Tony place thank you very much Mr president this is an example of another example of what I've been referring to in my discussions with many of you in the audience as a proactive leaning forward aggressive trying to stay ahead of the curve and what you seen now with this order is that we're gonna be able to remove the constraints so that people at the state the local level the individual physician all the way up through the federal government will have as many constraints as possible removed for them to do everything they possibly can so that we can implement the things that we've been talking about the containment the mitigation so that as I've said many times that curve that I referred to that goes up we don't want to have that curb we want to suppress it down to that small amount and I think what we've done today is something that is going to be a very important element and having us be successful in doing that we still have a long way to go there will be many more cases that will take care of that and ultimately as the president said this will end but what's going on here today is going to help the to end sooner than it would have thank you thank you very much Tony if I could some of these folks who we know they're celebrities in their own right there the biggest business people the greatest retailers anywhere in the world and one of them is Doug McMillan from Walmart and I'd like to have Doug if you would say a few words wherever you may be sure to place when we got the call yesterday from the White House we were eager to do our part to help serve the country and given what we're facing that's certainly important to do we should all be doing that so we've been asked to make portions of our parking lot available in select locations in the beginning and scaling overtime as supply increases so the people can experience a drop their experience that the president described will stay involved and do everything we can from the supply chain point of view to be of assistance thank you Sir thank you very much very much I'll just stay right over here and Richard if you could come up please Richard this Walgreens thank you yeah thank you Mr president and summer to to Duggan Walmart were happy to stand in here and helping communities all across America because a lot of times and we have natural disasters our stores or a beacon in the community and the situation is no different so we look forward to partnering with the CDC the administration HHS and the task force and specifically to the vice president's doing such a fantastic job we're ready to engage and help thank you thank you very much great Jeff thank you very much Brian Cornell target right thank you please well this present thank you for inviting us here today along with our colleagues from Walmart and Walgreens are partners at CVS normally you do you assist competitors but today we're focused on a common the better and that's the feeding the spread of the coronavirus and we look forward to work with the administration to do our fair share to alleviate this growing threat so thank you for including us today in the.

FDA
"fda" Discussed on KLIF 570 AM

KLIF 570 AM

03:52 min | 1 year ago

"fda" Discussed on KLIF 570 AM

"That make FDA regulated products for cause inspections ones in which the FDA is investigating a specific problem will be evaluated on a case by case basis if I suspended most inspections in China that was based on state department travel advisories at CDC and prevention and travel recommendations restrictions imposed on foreign visitors he said the agency will maintain oversight over international manufacturers and imported products using alternative tools and methods so this is going to increase concerns about US reliance on drugs ingredients made abroad as well as possible shortages due to corona virus a lot of medications used in the United States are manufactured overseas and are critical ingredients last month the FDA said one drugs in short supply due to virus declined to say which one the agency instead says that it may now I don't really rely more heavily on tools like tonight entry of unsafe products into the United States which of course is a problem because if you are denying entry to these products how exactly people get a hold of the medicine that they need when when you rely on the federal government's protected turns out the federal government is not very good at any of this okay in other news Harvey Weinstein has now been sentenced to twenty three years in prison according to The New York Times Weinstein once a powerful movie producer rule Hollywood for decades making breaking careers racked up Oscars reshaping the film industry but on Wednesday after years of private complains about his abuse of women burst into public scandal he was sentenced in a Manhattan court room two twenty three years in prison for raping one woman and sexually assaulting another startling sentence means they'll probably spend the rest of his life in prison just before the sentencing Weinstein told the court he was remorseful but also totally confused about what happened to him the sentence marks a significant milestone in the me too movement which ignited after several women openly accused Weinstein of sexual assault and harassment as well justice Ginsburg presided over the trial the state Supreme Court in Manhattan you hear the arguments prosecutors urged him to hand down a long sentence two of Weinstein's victims emotional statements about the damage done to them Mary Ann Haley testified why seem forced oral sex on her in two thousand six given a chance to speak once again suggested that he thought relationship to the victims were consensually said we may have different truths but I've remorse for all of you and for the men going through this crisis he said I really feel remorse for this situation I feel deeply my heart really trying I'm really trying to be a better person the justice was unmoved and gave Weinstein at twenty years for the felony attack on Haley an additional three years for the rape of Jessica man inspiring actors who said that he forced himself on her in a Manhattan so this obviously means that the me too movement has at least been successful in providing enough evidence to put one's name in jail once his lawyer said that the coverage once in case made a fair trial impossible because people had already basically decided on all of this that was an admin a long standing rumor in Hollywood the ones he was doing all of this this is not any sort of secret the real question is why all the same people who are celebrating one scene for years are shocked shocked to discover that this is what Weinstein was Hillary Clinton was out there taking pictures with Harvey Weinstein when everybody knew what Harvey Weinstein was doing people making jokes about Harvey Weinstein's sexual escapades to put it lightly over the Oscars something Farley made jokes publicly about it and now they're like oh I'm so glad what happened one scene where were you refusing to do business with this guy when it was widely known what he was in Hollywood before thanks to reporting in New York mainly by Ronan Farrow that's what got wind Steen put in prison it is pretty fascinating by the way how much of the media is going to cover up all one seems activity for years so once you decide to jail and that is a richly our reward for being one of the world's worst pieces of human to break okay just a second we're gonna get to the US women's soccer team which is now suing U. S. soccer on a flimsy basis well it's all of that in just one second first let us talk about a reality in business and in life the first impression makes a huge difference and that first impression depends on your smile so if your teeth are out of place for jeep look bad why exactly would you leave them that way instead do what I've been doing.

FDA