35 Burst results for "Drug Administration"
AP News Radio
Providers line up abortion pill alternatives ahead of court decision
"In Texas will here arguments today in a court case that could threaten access to medication abortion. Christian conservatives filed a lawsuit to overturn the Food and Drug Administration's more than two decade old approval of the abortion pill mifepristone, the alliance for defending freedom which filed the suit on behalf of several anti abortion groups and doctors is seeking an injunction that would force the FDA to revoke its approval of the drug which the alliance says has safety risks that were inadequately reviewed, hearing the case as Texas judge Matthew has Merrick, who was appointed by president Donald Trump, and has written critically of laws allowing abortion. There is essentially no precedent for a single judge overruling
AP News Radio
FDA's tobacco unit pledges reset after criticism
"The Food and Drug Administration is pledging a reset in the agency's tobacco program. The head of the FDA's tobacco center has promised to deliver a 5 year strategic plan by year's end outlining the FDA's priorities. The agency is responding to criticisms that its mission has been hampered by a lack of direction. The announcement comes as the tobacco center is besieged by criticism for its handling of both traditional tobacco products and newer vaping devices. I'm Shelley Adler
AP News Radio
No cow needed: Oat and soy can be called milk, FDA proposes
"The Food and Drug Administration is proposing that you don't need a cow to make milk. With things like almond milk and soy milk on the market, dairy producers have been pushing the FDA to crack down on plant based milk, saying it's a masquerade and clouds the real meaning of milk. But guidance from the FDA says these drinks don't pretend to be from cows and consumers aren't confused by the difference. Under the draft rules, the agency recommends labeling a product clearly by the plant source of the food. The rules also call for voluntary extra nutrition labels that note when the drinks have lower levels of nutrients than dairy milk, such as calcium, magnesium, and vitamin D, sales of non dairy milk are dwarfed by sales of traditional milk. Ed Donahue, Washington
AP News Radio
Abortion pill could be pulled off market by Texas lawsuit
"An abortion pill could be pulled off the market by a Texas lawsuit. A Texas lawsuit could threaten the nationwide availability of a medication for abortions, which is widely used in the U.S.. The case filed by abortion opponents who helped challenge roe V wade seeks to reverse a decades old approval by the Food and Drug Administration, a federal judge appointed by former president Trump could rule on the case this month. If he sides with the plaintiffs it could halt the supply of the drug called mifepristone in all states, both with abortion bans and without, the plaintiffs argue the drug was approved too quickly, but lawyers for the FDA say, that's not true. I'm surely Adler
AP News Radio
FDA moves to ease rules for blood donations from gay men
"Federal health regulators are taking steps to allow more people to donate blood by lifting some of the restrictions on gay men and others who are considered at higher risk of having the HIV virus. Current policy is gay bisexual men and others who engage in high risk behavior. Have to show abstinence for three months before donating blood. But doctor Peter marks a hematologist and a director at the Food and Drug Administration says better screening can end that waiting period. The new approach proposes that the current donor history questionnaire be revised to ask all prospective donors regardless of their gender about new or multiple sexual partners in the past three months. If the change is adopted, some will still be turned away. But more people will be allowed to donate. We believe that there will be no change to risk in the blood supply in terms of HIV, hepatitis B or hepatitis C the U.S. began restricting blood donations during the aids crisis in the 80s, but LGBTQ groups and the American medical association say that's no longer needed with better testing technology. I'm Jackie Quinn
AP News Radio
FDA's advisers back plan to simplify COVID-19 vaccinations
"The FDA is working toward making coronavirus vaccines more like an annual flu shot. Scientific advisers for the Food and Drug Administration are helping to decide how and when to update the recipe for COVID-19 vaccinations, and whether Americans need once a year boosters at an advisory panel meeting Thursday, the FDA's vaccine chief, doctor Peter Marx, says vaccinations should be made simpler. In order to facilitate the process of optimally vaccinating and protecting the entire population moving forward. Members voted unanimously that people should get the same formula for initial vaccinations or a booster to protect against prevalent strains. Many questions remain, like whether young people would really need yearly boosters and whether people with weak immunity might need two doses right now more than 80% of Americans have had at least one COVID-19 shot, but only 16% of those eligible for the updated boosters have gotten one. Jennifer King, Washington
AP News Radio
Justice Department investigating Abbott baby formula plant
"The Justice Department is investigating the infant formula plant that was shut down for months last year due to contamination. Abbott Laboratories says it's fully cooperating with the investigation into its Sturgis, Michigan facility. Abbott closed a factory after the Food and Drug Administration began investigating four bacterial infections among infants who consumed powdered formula from the plant. Inspectors uncovered several violations at the plant, including bacterial contamination, of leaky roof and lack safety protocols. But Abbott says its products have never been directly linked to the infections, which involved different bacterial strains. Abbott is just one of four companies that produce 90% of U.S. formula. I'm Mike Hempen
The Dinesh D'Souza Podcast
Twitter Censorship and the Covid Vaccine Debate
"The latest drop of the Twitter files comes from the journalist Alex berenson now. I've had Alex on the show some months ago now. And Alex has been focused on science reporting and of late specifically on reporting about COVID. And what's kind of interesting about these Twitter files is that Twitter files involve Alex themselves. So it's particularly appropriate that he be the one to blow the whistle on it. And I think Elon Musk is being very clever, very strategic. Matt taibbi, Barry Weiss, and now Alex Alex berns and there have been a couple of others as well. Now, this story begins with a guy named Scott gottlieb and Scott gottlieb is a director of Pfizer, Pfizer, the medical company. And he's kind of a big name on Twitter. He has about 550 thousand Twitter followers. In any event, it turns out that he sees a tweet gottlieb does. And he goes, wow, this is a tweet that may not be good for Pfizer. This is a tweet that might hurt Pfizer mRNA vaccine sales. And the tweet was from, yeah, it wasn't from some activist, wasn't from Robert F. Kennedy, junior wasn't even from berenson. It was from doctor Brett giroir, a physician who also had been himself as gottlieb was head of the Food and Drug Administration. And the tweet was not an anti vaccine tweet. In fact, it ended by saying get vaccinated, but the tweet went on to say, hey, listen, it says that the. Immunity that you get from the vaccine may not be as great as natural immunity. In fact, natural immunity provides more protection than vaccine immunity. Now, this is, in fact, a, an accurate statement by doctor Gerard. And in fact, the doctors cited a prominent study, a peer reviewed study that showed this. So it wasn't just that he was claiming it. It was that he was documenting it, and it's not even that Scott gottlieb disagreed with him. Start Scott gottlieb agreed that the factual statement being made was true.
AP News Radio
US approves Alzheimer's drug that modestly slows disease
"The Food and Drug Administration has approved a drug that modestly slows Alzheimer's disease. It's called la chembe, also known as lakena mab. It's designed specifically for those with mild or early stage Alzheimer's. Doctor Sam Gandhi at New York's Mount Sinai hospital says it focuses on amyloid material that builds up in the brain. There's a particular type of amyloid called the oligomer. That's especially toxic, especially poisonous. And looking at is targeted toward that particular most toxic species. The delay in cognitive decline brought about by the drug likely amounts to just several months. We don't know what rate they would have progressed. If they hadn't gotten them the medication. So it's in terms of whether the drug buys them 5 months or so. It's hard to know how people can relate to that. There can be side effects, like is a rare success in a field accustomed to failed experimental treatments for the incurable condition. Ed Donahue, Washington.
AP News Radio
FDA finalizes rule expanding availability of abortion pills
"The Food and Drug Administration has finalized a rule change that removes a long-standing requirement that abortion pills be picked up in person. It broadens the availability of abortion pills to many more pharmacies, including large chains and mail order companies. It updates the drug's labeling to allow prescriptions via any pharmacy that undergoes a certification process. Women can get a prescription through a telehealth consultation and then receive pills through the mail where permitted by law. The American college of obstetricians and gynecologists called the update an important step forward, more than half of U.S. abortions are now done with pills rather than surgery. The FDA says more than 3.7 million U.S. women have used the medications since its approval in 2000, the rule changes impact has been blunted by numerous state laws that limit abortion broadly and the pills specifically legal experts for see years of court battles over access as abortion rights proponents bring test cases to challenge state restrictions. Jennifer King, Washington
AP News Radio
Probe: Alzheimer's drug approval 'rife with irregularities'
"A report from congressional investigators finds many problems with the FDA's approval of a controversial Alzheimer's drug. Two House committees were investigating the Food and Drug Administration's approval of aju helm, made by Biogen, and reported the process was rife with irregularities, including an atypical collaboration between the regulators and the manufacturer. The report details in unusually high volume of phone calls, meetings, and emails. It also flagged Biogen documents, which said the company intended to make history with the high price of $56,000 a year for the drug. When the FDA approved aju helm in 2021, it overruled its own independent scientific advisers, leading some to resign. The investigators recommend the FDA take steps to restore trust in the approval process. Especially with a new Alzheimer's drug being considered in January. Jackie Quinn, Washington
AP News Radio
FDA clears updated COVID-19 vaccines for kids under age 5
"Federal health regulators have approved the latest version of the COVID-19 vaccination for use in the very youngest of children. The Food and Drug Administration has okayed the updated version of the COVID shot for children under the age of 5, even as young as 6 months old. These omicron targeted booster shots are made by Moderna and Pfizer already cleared for older kids. Only 3% of tots under the age of two have gotten any doses so far. So first they have to get the older version and then their third shot can be this new formulation. The FDA's vaccine chief says vaccinations are the best defense, especially during this time. When pediatric wards are filled with children suffering from the flu and the RSV virus. I'm Jackie Quinn
AP News Radio
US clear Novavax COVID booster dose
"U.S. regulators have cleared the COVID-19 vaccine made by novavax The new booster option is for people 18 and older who can't get the Pfizer and Moderna boosters for medical or accessibility reasons or who otherwise would not get a COVID-19 booster shot at all The Food and Drug Administration says the novavax shot is to be used only as a first booster at least 6 months after the primary shot The novavax vaccine is protein based unlike the other COVID-19 shots available in the U.S. about 48% of Americans who receive their primary vaccinations have never received a booster Mike Hempen Washington
AP News Radio
FDA clears updated COVID boosters for kids as young as 5
"The Food and Drug Administration is authorized updated coronavirus boosters for kids as young as 5 tweak boosters rolled out for anyone 12 and older last month Bill Gruber at Pfizer says a high number of kids under 12 have been hospitalized In part because they remain less well protected by vaccine So this is an opportunity with this good news to re energize interest in protecting children for the win The shots available are from Pfizer and Moderna doctor Jason newlin at Washington University in St. Louis says these are bivalent boosters They fight old and new strains Switching the bivalent vaccine targeting what we've currently continue to see circulate which is the BA 5 COVID-19 in our communities makes sense to make sure that our children are better protected against what we're seeing Less than a third of 5 to 11 year olds have had their two primary doses Ed Donahue Washington
AP News Radio
Arizona clinic has workaround for abortion pill ban
"And Arizona clinic has a workaround for the state's abortion pill ban a Phoenix abortion clinic has developed a way for patients who can end their pregnancy using a pill to get the medication quickly without running a bowel of a resurrected Arizona law that bans most abortions Under the arrangement patients at CamelBak family planning will have an ultrasound in Phoenix get a prescription to a telehealth appointment with a California doctor and then have it mailed to a post office in a California border town for pickup The Food and Drug Administration earlier this year permanently removed rules requiring in person consultations with a provider before
AP News Radio
FDA concedes delays in response to baby formula shortage
"And Drug Administration has conceded that there were delays in its response to the baby formula shortage I Norman hall the FDA says it's sluggish response to the U.S. infant formula shortage resulted from delays in processing a whistleblower complaint and test samples of the nation's largest formula factory The ongoing shortage has forced the U.S. to airlift millions of pounds of powdered formula from overseas Problems highlighted in a ten page report include outdated data sharing systems inadequate staff and training for food regulators and poor visibility into formula supply chains and manufacturing procedures The FDA says it will seek new authority to compel colonies to turn over a key information
WTOP
"drug administration" Discussed on WTOP
"Goose and local product Tariq Castro fields off waivers, the latter is an upper Marlboro native who started Penn State with Jahan dotson. That's my guy. Very hard worker. I spent a lot of time with him over the years. Trying to get better. He's going to fit this culture very well, you know? So there's a family around here. Guys are very close knit. He's just a great person to have around, so I can't wait to have him. Sound courtesy of ABC 7, Washington is also reportedly bringing linebacker John bostick back for a second stint. Rob woodfork sports. Thanks, rob, as always, 1217 on WTO P Among the top stories we're following for you, this midnight hour on TOP on your Thursday morning, a 70 year old girl locally is in the hospital this morning after being hit by a car, moments after she got off a school bus in Gaithersburg Wednesday. County police say a car when around a school bus that was stopped with its lights flashing and hit the young girl as she was crossing the road, the driver did stay on the scene, no word yet on any charges, in this case. Three teens were shot in two separate incidents in the district Wednesday, two of the teens were shot outside, the idea public charter school located in dean wood, one person has been arrested, the second shooting happened at 46th and Alabama avenue, southeast. The FDA Food and Drug Administration has this week authorized updated COVID-19 boosters that directly target most common omicron strains, pharmacies hope to they say start giving out the shot next week, provided the CDC Centers for Disease Control and Prevention approved them later this week. Today with WTO for more on these developing stories in just minutes, where the time now is 1218. I think it whether all the 8s and when it breaks, here's rich on her. All right, authorities still have the crash involving the motorcyclist on the antelope the valley approaching central avenue to get by single file to left as it continue clean up and investigation. If you're traveling in the district, I just got word of a closure due to police activity northbound 6th street in northeast at L street and that is one way north bound to Travis can only turn onto elf feet and go no further as a result of the closure. Also working on the freeway tonight, three 95 north or east as it were in into the third street tunnel, all traffic diverted to sea street southwest by the construction of your westbound on the freeway, you can go north into the tunnel, shout down in the third street tunnel headed south of New York avenue toward the freeway, single far right past the work tonight. Also working on independence avenue where they're paving again between 23rd and 17th street single file and both directions get you by Virginia new crash down in falkirk county and built in sat down 17 at route 28, south island lanes temporarily stopped as they continue to crash, clean up their northbound traffic was getting by. If you're traveling on 66, eastbound as you head east of a market toward Gainesville single right link you buy between 29 centimeter and the fairfax county Parkway, single file right gets past that at 50 again down to a single right lane, and then as you approach and pass nutley's tree to headed toward the beltway, two left lanes get you by the construction, rich hunter WTF traffic Temperatures the next couple of days are going to be above average and close to that 90° range once again, the good news is not a lot of humidity after that front move through during the day on our Tuesday and Wednesday
AP News Radio
Germany: EU could OK combined COVID vaccines next month
"Germany's health minister Karl loiter back says E regulators may authorize the use of vaccines that are each effective against two variants of the coronavirus low to back expects the European medicines agency to meet on September 1 to consider a vaccine that would provide protection against both the original virus and the so called omicron variant also known as BA one the U.S. Food and Drug Administration has said the combination vaccines known as bivalent or multivalent shots will allow boosters to retain the proven benefits of original coronavirus vaccines while providing additional protection such an approach is used with flu shots which are adjusted each year depending on the variants that are circulating I'm Charles De Ledesma
AP News Radio
FDA: Take 3 home tests if exposed to COVID to boost accuracy
"Federal health officials say if you were exposed to COVID-19 take three home tests instead of two to make sure you're not infected I Norman hall The Food and Drug Administration had previously advised taking two rabbit antigen tests over two or three days to rule out infection but the agency now says new studies suggest the protocol may miss to many infections and could result in people spreading the coronavirus to others especially if they don't develop symptoms The new guidance applies to people without symptoms who think they might have been exposed People with symptoms can continue using two tests based 48 hours apart Antigen tests which are less sensitive than lab tests have become the standard testing approach due to their speed and convenience Norman hall Washington
WTOP
"drug administration" Discussed on WTOP
"23 the commissioner of the Food and Drug Administration Robert califf is back before Congress today He'll testify before a Senate committee about the baby formula shortage yesterday caliph was criticized by House lawmakers after months of delays investigating problems at the nation's largest baby formula plant Caleb says a COVID outbreak at the plant delayed the investigation there and he admitted that a whistleblower complaint didn't reach FDA leadership because it was apparently lost in the mail The nation's first federally backed test to treat site for COVID-19 opens today in Rhode Island patients will get immediate access to the antiviral COVID treatment pax lovid if they test positive more of the sites will open in the coming weeks in Massachusetts and New York City both places have recorded increases in infections across the nation infections have quadrupled since late March jumping from about 25,000 a day to more than 100,000 However deaths in the nation have plateaued at fewer than 300 a day Passengers on a cruise ship carnival magic have become ill after reporting a chemical smell on the ship The coast guard says it received reports that passengers were nauseous and vomiting from the fumes The ship is in transit to Norfolk Virginia from The Bahamas members of the coast guard will board the ship to investigate when it arrives there today carnival magic can carry about 4000 passengers It's the largest cruise ship to ever sail out of Virginia A lot of folks moved out of America's big cities during the first year of the pandemic The Census Bureau says 8 of the nation's ten largest cities lost population from 2020 to 2021 only Phoenix in San Antonio grew New York losing the most residents about three and a half percent of its 2020 population.
WTOP
"drug administration" Discussed on WTOP
"Community and tear up another community This is time to build the community not tear it apart I'm Stephen portnoy at The White House where press secretary karine Jean Pierre read the names of the buffalo victims Pearl young 77 was a substitute teacher and a true pillar in the community Jean Pierre said the president would comfort families on a visit to buffalo tomorrow She said he would call out race based hatred but not the people who espouse it Once you get into calling out people's names then you move away from that issue Some Cuba restrictions are being lifted CBS Ed O'Keefe Divided administration is reversing Trump era policies regarding Cuba with plans to expand flights to the island nation expanding consular services there and relaunching family reunification programs that have been shut down in recent years Amid a shortage of baby formula formula maker Abbott says it has come to an agreement with the Food and Drug Administration to restart production at its factory and Sturgis Michigan The FDA had been investigating bacterial infections in four babies who consumed powdered formula from the plant two of those babies died CBS News medical contributor doctor David agus this was an aggressive action stopping the plant as a whole which affected many lives across the country But the hope is there will be a safer plan going forward Ukraine says more than 260 fighters have been evacuated from a steel plant in the city of mariupol and taken to Russian controlled areas BBC's Russia editor Vitaly Shevchenko For Ukraine it means that the lives of the defenders of as of in maru pole at least some of them have been saved And these people are genuinely seen as heroes in Ukraine So at this point the public in Ukraine believes that they've made their stand They have shown what they're made of Now it's all about saving their lives New Yorkers are masking up again New York City health officials want New Yorkers to wear masks indoors again as a city approaches high risk COVID alert status That includes grocery stores offices and any other indoor venues Anyone over 65 is also urged to avoid crowds and non-essential gatherings New York City has been averaging about 3600 new cases of COVID per day over the past week and these are just reported cases experts say the real number is likely much higher because the count does not include home tests Monica ricks CBS News New York This is CBS News Never miss a moment top news from WTO 24/7 360 five Listen on air on Alexa and on the.
WTOP
"drug administration" Discussed on WTOP
"King The FDA Food and Drug Administration is now strictly limiting who can get J&J Johnson & Johnson's COVID vaccine because of an apparent rare but serious risk of blood clots This morning CBS News medical contributor doctor David agus gives us the rundown of who's still allowed to get the J&J vaccine So it's important that there were only 60 cases of these blood clots in 17 million vaccines but adults who had a reaction to an organic vaccine and can't get it or those who say I won't take any other vaccine can still get the J&J but we know there are more side effects to J&J this rare blood clot So it makes sense to get the RNA vaccine You point out how rare the problems are with this vaccine but why not just pull it off the market Well I mean there is a cohort of people that has had a reaction to the RNA vaccines And so this makes it available to them And then there's a group that says listen I just won't get an RNA vaccine So it's better than no vaccine Again the side effects are remarkably rare 17 million people are protected because of this vaccine and that is awesome And if somebody says I'm not going to get it I'd rather them get this vaccine than no vaccine It's no estimated that COVID-19 has killed more than 1 million Americans and the virus took more lives here than in any other country I wanted to get your thoughts on that Yeah it's really shocking numbers The WHO said they think there's 16 million worldwide debt So dramatically higher than what have been reported Mainly because a lot of people weren't tested and died of the disease And a lot of people who had heart disease cancer and others couldn't get into the hospital because the hospitals were full So our response early on was dismal The hope now is with the vaccines with the boosters with the drugs that we have to treat the virus that we're going to live with the virus going forward and not high from it I hope it's a new era and we've learned from the past COVID case counts though are rising in some parts of our region here in the D.C. area as well as in other parts of the country We haven't seen as far as I've seen any hospitalization spikes What's your advice as we head into the warmer weather and vacation time this summer It's real I mean COVID is still here And again get that booster shot please If you have high level of immunity with that booster shot you're going to have a mild cold at best when you have this If you don't your vaccines were a long time ago or you weren't.
WTOP
"drug administration" Discussed on WTOP
"FM double DTP dot com of course of the WTO PF where the time is two 22 The FDA Food and Drug Administration is now strictly limiting who can get J&J Johnson & Johnson's COVID vaccine because of an apparent rare but serious risk of blood clots This morning CBS News medical contributor doctor David agus gives us the rundown of who's still allowed to get the J&J vaccine So it's important that there were only 60 cases of these blood fats in 17 million vaccines but adults who had a reaction to an RNA vaccine and can't get it or those who say I won't take any other vaccine can still get the J&J but we know there are more side effects to J&J this rare blood clot So it makes sense to get the RNA vaccine You point out how rare the problems are with this vaccine but why not just pull it off the market Well I mean there is a cohort of people that has had a reaction to the RNA vaccines And so this makes it available to them And then there's a group that says listen I just won't get an RNA vaccine So it's better than no vaccine Again the side effects are remarkably rare 17 million people are protected because of this vaccine and that is awesome And if somebody says I'm not going to get it I'd rather them get this vaccine than no vaccine It's no estimated that COVID-19 has killed more than 1 million Americans and the virus took more lives here than in any other country I wanted to get your thoughts on that Yeah it's really shocking numbers The WHO said they think there's 16 million worldwide debt So dramatically higher than what have been reported Mainly because a lot of people weren't tested and died of the disease And a lot of people who had heart disease cancer and others couldn't get into the hospital because the hospitals were full So our response early on was dismal The hope now is with the vaccines with the boosters with the drugs that we have to treat the virus that we're going to live with the virus going forward and not high from it I hope it's a new era and we've learned from the past COVID case counts though are rising in some parts of our region here in the D.C. area as well as in other parts of the country We haven't seen as far as I've seen any hospitalization spikes What's your advice as we head into the warmer weather and vacation time this summer It's real I mean COVID is still here And again get that booster shot please If you have high level of immunity with that booster shot you're going to have a mild cold at best when you have this If you don't your vaccines were a long time ago or you weren't vaccinated.
WCPT 820
"drug administration" Discussed on WCPT 820
"And nearly all of us reach for the pillow bottle on occasion is perfectly safe though because the Food and Drug Administration regulates the ingredients that go into those medicinal compounds right Yes assuming they're produced in the USA Aren't they Mostly no Take antibiotics The New York Times reports that ingredients for the majority of these bacteria fighters are now made almost exclusively in China and India As are the components of dozens of other major drugs Unbeknownst to most Americans and to our doctors China has become the world's preeminent supplier of medicines As one major drug company puts it if tomorrow China stops applying pharmaceutical ingredients the worldwide pharmaceutical industry would collapse What's at work here is mindless globalization and deregulation Our politicians threw open the U.S. market to drug imports while also letting foreign manufacturers go uninspected and unregulated Companies located in China can cut corners and undercut our own regulated pill makers America's last producer of penicillin's ingredients for example shut down in 2004 leaving us dependent on China FDA are supposed watchdog doesn't even know where a drug's ingredients come from Why Because drug companies say they don't like to reveal their sources So they don't The times found that one federal database lists the existence of about 3000 foreign drug plants that shipped to the U.S. while another list 6800 No one knows which is correct If either this is Jim Hightower saying this is ridiculous For the sake of America's health.
TIME's Top Stories
"drug administration" Discussed on TIME's Top Stories
"By Alice park. President Joe Biden nominated doctor Robert caliph, a former commissioner of the Food and Drug Administration to head the agency again. Biden's nomination will now go to Congress, which has to confirm caliph. Since Biden took office, health officials have been waiting for him to appoint a new head after doctor Stephen Hahn, who was widely criticized by the scientific community for not taking a stronger stand against the Trump administration's support of unproven COVID-19 therapies, left the post in January. The FDA is the regulatory agency responsible for reviewing the safety and efficacy of drugs, devices, and medical therapies, and is the key gatekeeper for evaluating new COVID-19 vaccines and drug treatments. Biden left the position open for nearly maximum time allowable by law, he had until November 15th to appoint a new commissioner, which some medical experts say have not helped public confidence in the agency's decisions in the meanwhile. On the other hand, Biden appointed doctor Rochelle Walensky to take charge of the Centers for Disease Control in December, even before he himself took office. The FDA has been mired in controversy throughout the pandemic, early in 2020, the agency granted emergency use authorization for hydroxychloroquine, the malaria medication that early studies suggested might help to treat COVID-19 and was championed by Trump, but turned out not to provide much benefit. The agency later withdrew its authorization. In August 2020, the FDA also granted an EUA for convalescent plasma or plasma obtained from recovered COVID-19 patients and re infused to help new patients. But later limited issues to plasma from certain types of patients who had the most robust responses to their natural infection. Then in June of this year, the FDA approved a controversial Alzheimer's drug the first treatment for the disease, despite concerns raised by many Alzheimer's experts about the robustness of the data showing benefit for patients as measured by cognitive tests. FDA officials also met with one of the drug company scientists at a scientific conference, which may have been inappropriate for a regulatory agency that is tasked with objectively reviewing safety and efficacy data for a drug. Caliph, a heart disease expert at duke university, served as head of the FDA for a year under president Barack Obama, he brings to the agency a strong understanding of the clinical trial process, which provides the data the FDA reviews in order to approve new drugs, having served as vice Chancellor for clinical and translational health at duke university. It was also a senior adviser to Verily life sciences and Google health. However, there have been concerns raised about where his allegiance is lie. During his September 2016 nomination hearing for the role under the Obama administration, he was grilled by several Democrats, including senators Elizabeth Warren, and Bernie Sanders, who questioned his close ties to the pharmaceutical industry. In a 2017 podcast, caliph admitted that during the hearings, Warren put me through hell and questioning how clinical trials work in the relationship and role of industry in that process. During caliph's brief tenure at the FDA, he overruled the advice of the agency's expert advisory committee on the drug at a person, a new treatment for muscular dystrophy. The committee thought the risks of the drug outweighed the benefits, caliph approved the drug backing the decision of his officials making the argument that under accelerated approval, which kicks in when there is an unmet need and no available treatments for a rare condition, FDA has authority to grant approval, it believes is in the best interests of patients. Already, senator Joe Manchin of West Virginia, a Democrat who opposed caliph's first nomination over his perceived closeness to pharmaceutical interests that perpetuated the opioid crisis, voiced his continued opposition to caliph taking over the FDA. Doctor Calif nomination and his significant ties to the pharmaceutical industry take us backwards, not forward. Mansion said in a statement reacting to Biden's choice. His nomination is an insult to the many families and individuals who have had their lives changed forever as a result of addiction. I could not support doctor calas nomination in 2016, and I can not support it now. Still, in 2016, caliph was ultimately confirmed by an 89 to four vote..
AP News
"drug administration" Discussed on AP News
"Drug Administration's vaccine program, says he's very hopeful younger Children will be eligible for Covid vaccines Before year's end. Dr Peter Marks of the FDA tells The Associated Press. The agency will quickly evaluate Covid 19 shots for kids ages 5 to 11 as soon as it gets the necessary testing data, But he says he's very hopeful it could happen in months or even weeks. Both Pfizer and Moderna are testing vaccines on young Children. Even babies, with study results expected soon. Right now only people aged 12 and over can get a vaccine. But with a Delta variant spreading rapidly among Children, many parents are getting concerned. Jacki Quinn, Washington There's a new village at Fort Bliss in Texas of Village built to house thousands of evacuees from Afghanistan. The bite administration allowed the media in to get a look at one of eight military installations created to house Afghan citizens who had to flee their homeland. It's a sprawling area with air conditioned tents to provide dormitories and dining halls and brigade commander Colonel Michael Wagner says the refugees at the El Paso base are first screened for Covid 19 and given a vaccination assigned To housing and then help them move out to accommodations. The military says. The nearly 10,000 visitors also undergo security screenings at this point, none of the evacuees at Fort Bliss has yet been released for resettlement. I'm Jackie Quinn, the president's executive order setting vaccine mandates for both public and private employers. Touches off a chorus of legal threats from GOP governors. Florida Governor Rhonda Santa's fears massive job losses, This order would result potentially and millions of Americans losing their jobs. But Jonathan Cherif, the CEO of a company that runs a number of car dealerships in South Florida, says two of his workers have died. And a number of others had to leave the job because of long term effects of Covid 19. We need to get it under control. We need to be able to go forward in our lives. As we once noted at the La Fonda on the Plaza Hotel in Santa Fe, New Mexico, general manager Rick Blythe says 85% of his staff of well more than 100, people are vaccinated. And the mandate will eliminate his concerns about guests who may or may not be vaccinated. Having my step back state is one thing, and that's great, and I'll be very happy about that, but also knowing that a lot of people walking through our doors are working for bigger employers, hopefully, and they're also vaccinated. I'm Tim McGuire..
Wall Street Breakfast
"drug administration" Discussed on Wall Street Breakfast
"Us food and drug administration grants full approval for the kobe. Nineteen vaccine that was developed by pfizer and bio and tech walmart will offer its delivery service to non walmart businesses and elon. Musk said tesla's pilot version of a more advanced driver. Assistance software is actually not great those stories and more but first let's get you caught up on markets. Us stock futures are modestly higher with dow smp nasdaq futures showing a gain of as much as three tenths of a percent shares in asia closed higher with stocks in hong kong rising two and a half percent while in china. The broad-market gained more than one percent. Oil prices are up more than one percent. The fda has officially approved the pfizer bio intech vaccine for kobe. Nineteen sending both stocks higher in. Monday's trade the vaccine will be available for those sixteen years of age and older. The approval may create more momentum in vaccine trends especially in states in population groups. That are lagging. That's according to joe amato chief investment officer at neuberger berman walmart is opening up. Its spark driver service to third party. Vendors drivers can make additional deliveries of non walmart merchandise. The new service called walmart go. Local will feature non walmart branded delivery vehicles and relies on a combination of delivery and gig workers. The service is set to begin by the end of the year in a new exchange over. Twitter tesla's chief executive elon. Musk called the latest release of the company's experimental driver assistant software quote. Actually not great the prototype. Software is only available at tesla employees and some drivers who previously purchased full self driving capability which costs ten thousand dollars or one hundred ninety nine dollars per month in the us. Musk added that the autopilot. Ai team is rallying to improve as fast as possible and said quote just drove from pasadena to lax much improved there are different stages of self driving capabilities ranging from level one through level five according to the automotive engineering society s. a. e. international tesla's pilot version is currently no more than a level to where the car can do the steering acceleration but the driver must be ready to take the wheel in other news. Prices of corn and wheat are rising as extreme heat and key growing regions such as north and south dakota minnesota iowa and nebraska hurts crops more than sixty percent of the us. Spring wheat crop is classified as poor or very poor. That's compared to just six percent last year according to the us department of agriculture so far this year corn and wheat prices are up more than ten percent projections for crop. Production and other countries such as brazil and russia have also been reduced. The federal aviation administration is beginning. A review into how boeing workers implement safety directives from the agency. Richard branson's virgin global is going public and a three point. Two billion dollars back deal. Company said that boeing will invest in the listing later this year. Samsung said it will increase investments in semiconductors and biotech to more than two hundred billion dollars over the next three years target plans to add more disney.
WTOP
"drug administration" Discussed on WTOP
"The Food and Drug Administration has granted full approval to fighters covid vaccine for people 16 and older. We talk with CBS news Medical contributor Dr David Agus about the FDA s review of the vaccine, and if we're going to see full approval for Madonna and J and J it was an exhaustive review. Tens of thousands of pages have been reviewed of all individual patient data, and it works and it is safe and it is manufactured well with high quality. So remarkable events from fighter fighter did this without government funding did this themselves And they have gotten it first. Moderna has not yet submitted their full approval and either as J and J so there will be several months behind. Before this, the Pfizer vaccine had been authorized only for emergency use. Meantime, now that Pfizer's vaccine has full approval, the Defense Department is moving ahead with plans to make the vaccine mandatory for all military personnel. The department is prepared to issue updated guidance requiring all service members to be vaccinated. A timeline. For vaccination completion will be provided in the coming days as Pentagon spokesperson John Kirby to Afghanistan. Now we're getting an update on the pace of evacuations. Major General Hank Taylor says. Dozens of flights have left Kabul in the past 24 hours. The total passenger count for those flights who was approximately 16,000. Of that number the U. S military transported just under 11,000 personnel. It comes as there was a deadly attack as Kabul International Airport. U. S troops were involved, but they were not injured. One Afghan soldier was killed, though it started as an exchange of gunfire between Afghan special operations forces and either Taliban members. Isis are angry Afghans outside the airport. At least 20 people have been killed in the chaos at the airport so far, most in shootings in stampedes as U. S and International forces try to evacuate citizens and vulnerable Afghans. The mission to get Americans and Afghans out of Kabul has been complicated because of concerns about terrorists. The Taliban is released thousands of hardcore Isis and Al Qaeda fighters in its march to Kabul so the problem is simple. No one knows where they are. But sources I've spoken to on the ground say they are looking for ways to target Americans, Afghans who helped the U. S in the war effort and others. We've heard reports of shootings, beatings and Americans being impeded from getting to the airport. Real current and former U. S. Intelligence officials say We need to remember devices seeks to kill Americans in horrible ways, including beheadings. JJ Green W. T. O P News just ahead. Members of the House returned to Capitol Hill in hopes of tackling some major legislation today. It's 12 34 the first metal. She's a sports.
Newsradio 1200 WOAI
"drug administration" Discussed on Newsradio 1200 WOAI
"To the Food and Drug Administration, sending information from its covert 19 vaccine studies. That's part of the process to get full U. S regulatory approval for the vaccine in adults. Visor and its German partner by on Tech applied for full approval of their covert vaccine. Last month, Madonna's vaccine was given the OK for emergency use by the FDA in December, and so far more than 124 million doses have been administered in the U. S. Last week, Madonna announced that the vaccine is safe and effective for kids as young as 12 and plans to seek emergency authorization for team use this month. Meantime, President Biden is said to give an update today on the nation's fight against Cove it. His goal is to have 70% of adults with at least one vaccine shot by the fourth of July. So far, 12 states, including Texans have hit that mark early with five. Other still under 40%. The president also wants 160 million people fully vaccinated by the holiday. The CDC shows that number is nearing 136 million, which is roughly 41% of the population. 35% of Texans have been fully vaccinated. We'll close call for about Connie's Heights Police officer who was almost run over it happened around 2 30 this morning in the parking lot of the Springhill Suites on Luke 14 in Fredericksburg Road. The officer confronted a suspected car burglar who was inside a vehicle in the hotel parking lot. And the 19 year old suspect failed to follow any verbal commands from the officer and instead got back into his vehicle and try to run the officer over as he was trying to get away. The officer fired one shot towards the vehicle, which then drove off. A short pursuit ensued. But the suspect Identified is Jonathan Martinez crashed his vehicle, then took off on foot before being captured with the help of an essay PD Chopper. The state government in cities and counties across Texas and more than a billion federal dollars and rental assistance money. Nobody's applied for Texas received more than a billion.
WZFG The Flag 1100AM
"drug administration" Discussed on WZFG The Flag 1100AM
"The Food and Drug Administration is trying again to ban mental cigarettes. Decision based clear science and evidence establishing the addictiveness and harm of these products and builds on important previous actions that band, other flavored cigarettes in 2000 and nine acting FDA Administrator Dr Janet Woodcock. African American health groups have asked the agency to remove the flavor, which is popular among black smokers. It's the only flavored cigarette that wasn't band more than a decade ago. A people Evan, indicted by a grand jury on charges ranging from involuntary manslaughter to hazing for the alcohol related death of an Ohio College student who was found unconscious by his roommate last month. Stone false died three days after he and other Pi Kappa Alfa pledges at Bowling Green University or each given and encouraged to finish an entire bottle of alcohol. The university expelled Pi Kappa Alfa fraternity earlier this month after charging it with violating six code of conduct rules. The death who has renewed calls for Ohio lawmakers to increase criminal penalties for hazing. They're a couple of encouraging readings on the economy. New claims for unemployment benefits declined by 13,000 last week to 553,000 design of continued improvement in the job market and the economy continued to rebound in the start of the year. The gross domestic product rose 6.4% in the first quarter. Economists have been predicting a rebound in the labor market this spring and predicted an improvement in the GDP. With more Americans vaccinated and more restrictions lifted. Consumer spending jumped more than 10% early this year, helped by stimulus payments to Americans in January and March. Jenny Cho Silda Fox News E. D. C is considering allowing cruises to begin setting sail in the U. S. Starting this summer. I'm least Scylla, Sarah.
Biz Talk Radio
"drug administration" Discussed on Biz Talk Radio
"Message from the U. S Food and Drug Administration. Everywhere. Okay. Thank God. It's not infecting the markets markets holding pretty strong here. Um, I like what I'm seeing. And for now, um, stimulus out of Washington keeps Mr market happy. So we're watching that, um, I'm all over that. But this cove ID stuff is getting crazy. Okay, Now, I was talking to, um My friend who works in my local bagel store. Okay, The guys from Pakistan. He's naturalized citizen work taught. He owns a bagel store right? And he said was going on Jandi with this testing the numbers down, people up. I see people online and I said, you know, It's crazy, isn't it? Because they gotta so psychologically scared that if you're gonna go here, there everywhere then you want to get tested quick and the more you test, he says, You know what? It's free. That's why everybody's going like mad because free so the government is testing you for freight so crazy now, if you think that's crazy, which I do, okay, Because if you have no symptoms, why do you gotta go get tested? And then what if you sneeze, then which would usually be a cold? The common cold is gone. It's like it doesn't exist anymore. If you sneeze, you got cold feet. You got to run down and get a test and then get a PCR to back it up and get another wrap it. It's like it's going out of control. I love to see who's getting all the money for this testing. Um.
News-Talk 1400 The Patriot
"drug administration" Discussed on News-Talk 1400 The Patriot
"Town hall dot com. I'm Jason Walker, the government's top infectious disease expert, says the United States hopes to start vaccinating youngsters within the next few months. White House correspondent Greg Clugston has more at a White House coronavirus briefing, Dr Anthony Fauci said kids vaccines hopefully will start to happen by late spring or summer. However, the Food and Drug Administration has yet to approve vaccines for Children and at the moment older adults are having problems finding available shots, Fauci said. Getting Children vaccinated is a necessary step to securing wide spread immunity to the coronavirus. Great Clugston, the White House Senate Republicans calling on President Biden to meet them at the negotiating table as he signals he could move to pass a new $1.9 trillion virus aid package with old Democratic votes. GOP leaders say they're less costly counter proposal includes $160 billion for vaccines as well as testing Also at town hall dot com. Australia says the lack of competition for Google the lack of transparency in the digital advertising supply chain need to be addressed because they're impacting publishers, Advisors and consumers. Here's Jeremy House, the Australian Competition and Consumer Commission released an intern report on its inquiry into the Google dominated digital advertising services industry in Australia. It notes Google not only powers the digital display technology, it also controls much of the advertising space. The commission chairs and there was often a real lack of choice and transparency in the industry..
KOMO
"drug administration" Discussed on KOMO
"Lose 7 1097 7 Online at Comeau News Calm This is KOMO Seattle KOMO FM Oakville From ABC News. I'm Richard Can sue Donald Trump's impeachment trial in the Senate may be pushed back a little bit. Republican leader Mitch McConnell is proposing the trial be delayed for at least two weeks, saying Trump needs more time to prepare because the Senate cannot short circuit the due process. House Democrats who voted to impeach Trump last week for inciting the capital riot have signaled they want a quick trial. With Democrats now controlling the Senate. It's up to majority leader Chuck Schumer, too. Lay out the timeline. Schumer's office says they're reviewing McConnell suggestion maybe sees Elizabeth, Chelsea and Washington warning the pandemic will get much worse before things get better. President Biden sign Maura executive orders aimed at combating the virus death toll will likely top 500,000 next month. Cases will continue to mount. One of his orders requires mask wearing it federal properties and an interstate travel airlines trains Busses public health experts blame vaccine shortages on the previous administration, vastly expanding vaccination drive to reach senior citizens. Anthony Fauci unleashed. Appearing in his first briefing with the new administration, the infectious disease expert recounted working under the previous administration. The idea that you can get up here And talk about what? You know what evidence? What the sciences and no, That's it. Let the science speak. It is somewhat of a liberating feeling. US Food and Drug Administration approved cabin UVA first long acting drug combo for HIV. It's a monthly to shot combination that can replace the daily pills now used Supposed to make it easier for people to stay on track with their HIV medications. The Vatican's criminal tribunal convicted 81 year old former Vatican Bank chief Angelo Kel Oya and his 97 year old lawyer convicted them of embezzling millions of euros from Vatican owned real estate sales sentenced each to nearly nine years in prison. You're listening to ABC news. In the coma. 24 hour news room on Rich, sly inspire, broke out yesterday in a potato processing plant in Warden Washington threatening a tank which could explode. So it zone ammonia tank That's right next to the building of song Fire, And so it's a zoo director being hit by planes right now, so the risk of this exploding Kyle Foreman with Grant County Fire says people left their homes to escape the danger. In counties, covert numbers are improving. Health officer Dr Jeff Duchin says. The case rates and desert down at least temporarily. Additionally, 74% of licensed nurses in King County have been vaccinated. 70% of physicians and surgeons have been vaccinated. 77% of physician's assistants have been vaccinated, but not everyone who's eligible for the vaccine is able to get it and Dr do, Jin says. That could reverse the current trends. Here's traffic.
KLIF 570 AM
"drug administration" Discussed on KLIF 570 AM
"Reported in the U. S on Monday of variant of the Corona virus still spreading in Britain that country locking down again for another six weeks. British Prime Minister Boris Johnson reimposing a sweeping state home order our hospitals around the more pressure from Cupid. Them any time since the start of the pandemic. Johnson blames a new variant of the virus, which he says is particularly contagious. It's being both frustrating on alarming to see the speed with which the new variant is spreading. Much of England is already under significant covert restrictions, but the rules are being tightened further. With schools now closed in London. Simon Ellen Fox News and Drug Administration, responding to reports that it might change the dozing for the Corona virus vaccines, saying the suggestions or premature and not rooted in the evidence available. Wisconsin in the hospital. Pharmacist whom police say admits to deliberately trying to spoil hundreds of doses of the vaccine, reportedly thought the shots would alter patients. Didna is free on bond awaiting trial in South Carolina, some home improvement yields to a grim discovery. The Spartanburg County Quarters office investigating what it calls fetal skeletal remains that were found in the wall of a home in Pakal. It remains discovered during renovation of the home and believed to have been concealed in the wall for long. Long period of time. Efforts are underway to interview people or relatives of those who lived in the home. The remains will also be submitted to a forensic anthropologist in an examination that we're told could take months. Jeff Man, also Fox News, the 3.5 year long boycott of cutter by Saudi Arabia and many of its allies. Is ending with a golf summit in Riyadh today, which the Amir of cutter has survived for I'm Jack.
KSFO-AM
"drug administration" Discussed on KSFO-AM
"Coronavirus cases reported in the U. S on Monday of variant of the Corona virus still spreading in Britain that country locking down again for another six weeks, British Prime Minister Boris Johnson reimposing a sweeping state home order. Our hospitals are under more pressure from Kobe. Any time since the start of the pandemic. Johnson blames a new variant of the virus, which he says is particularly contagious. It's being both frustrating on alarming to see the speed with which the new variant is spreading. Much of England is already under significant covert restrictions, but the rules are being tightened further. Schools now closed in London. Simon Ellen Fox News Food and Drug Administration, responding to reports that it might change the dozing for the Corona virus vaccines, saying the suggestions or premature and not rooted in the evidence available in Wisconsin, the hospital pharmacist who police say admits to deliberately trying to spoil hundreds of doses of the vaccine. Reportedly thought the shots would alter patients. DNA's free on Bond awaiting trial in South Carolina Some home improvement yields to a grim discovery. The Spartanburg County Quarters office investigating what it calls fetal skeletal remains that were found in the wall of a home in Pakal. It remains discovered during renovation of the home and believed to have been concealed in the wall for a long period of time. Efforts are underway to interview people or relatives of those who lived in the home. Remains will also be submitted to a forensic anthropologist in an examination that we're told could take months. Jeff Manasso, Fox News The 3.5 year long boycott of cutter by Saudi Arabia, and many of its allies, is ending with a golf summit in Riyadh today. Which the Amir of cutter has arrived for. I'm Jack Keller here. This'll is Fox News..