29 Burst results for "Janet Woodcock"

"janet woodcock" Discussed on Pod Save America

Pod Save America

04:52 min | 3 weeks ago

"janet woodcock" Discussed on Pod Save America

"That'll be kind of left to the cdc to determine exactly what that means after the fda commissioner acting commissioner. Janet woodcock makes a recommendation based on this advisory committee recommendation. She spoke to. I do think that's really important that that a lot of people could miss. Is that this advisory committee. Their job is to advise the fda commissioner. Her job is to take a whole bunch of different things in consideration including their advice. Yes and then that goes to the cdc and then that will lead to more specific recommendations and by the way that thing goes to governors who can make recommendations based on They can follow those. They can adjust those. I think probably because of the kind of lethargic pace by which they have been making these kinds of reputations see governor larry hogan ingmar in maryland getting ahead of it and saying i'm recommending for over sixty five starting right now so janet woodcock gave an to anti slab it on his podcast and she said if people are wearing the virus spreading it. You want to stop that as much as possible. She was very kind of opaque and vague but that is important because she made her decision. She's made her decision. Apparently well right. We don't know didn't announce it on. Oh but that sounds like okay. So it's interesting. We don't know what it means. It seems like one hopes that it's going to be a broader recommendation than what the the advisory committee said but was important about it is some of this. Debate is what should inform the recommendation. Like how away. When a vaccine is still effective against severe disease hospitalization but less so against a symptomatic and mild moderate illness so fao g was interviewed by the post about this and he said some scientists believe it is okay for vaccinated people to get infected as long as they experience only milder moderate symptoms but as a clinical person who sees a lot of patients. That isn't okay. Adding that even mild infections can result in missed work disruptions of family life and potential cases of long cove it with its debilitating effects and the the biggest part of it is if if boosters can significantly lower your chances of getting infected in the first place and thus lower the chances that are vaccinated person might transmit the virus to someone else. Then boosters will help control the spread now. We don't know how long the booster you know. The the added immunity from the booster last because the data is still out on. That and israel is ahead of us. But they're not that far ahead of us so we don't know yet but if we could slow down transmission and reduce transmission by giving people boosters. That's not just like a for an individual. that's a benefit for all of society. So i don't have a fucking understand what they're here. Counterpoint eighty percent of vaccine doses have gone to rich white countries. I think point four percent of vaccine doses have gone to the poorest countries in so we are in a situation. We're gonna have like a bunch of people in america with their third and fourth those the the next variant is still going to emerge from someplace else. Oh globally like. I just finished talking about this in his pike as to. That's not the issue with vaccinating the rest of the world. it's not the number of doses if we took all the doses we bought for Another booster shot and started shipping them around the world. We still wouldn't solve the real problem with getting the rest of the world vaccinated which is the last mile logistics issue. We need more people on the ground or but you start with a finite number of doses. That's why we have more doses right now we are. We are not using as many doses. We are producing globally everyday right now. This is an important debate. It is a political debate about how to distribute vaccines. The reason like i am frustrated. If the fda advisory panel wants to say we think boosters would help all americans but we don't want them to have them right now because we want them to go abroad fine but they're actually kind of combining the political calculus in the scientific calculus. The thing that has been the most frustrating to me is when public health officials throughout this pandemic have taken off their scientists hat and put on their pundit hat and so you know That's what happened with mass early on we are still paying for that and a lot of ways. So two of the members of the fd advisory committee wrote this piece in the in the lancet preempting. The advisory committee meeting saying boosters should not be recommended and then now inside of that piece they do a lot of analysis of data hard data that is for the scientists and experts and but was really frustrating about it is throughout the peace. They say if unnecessary boosting causes significant adverse reactions there could be implications for vaccine acceptance. They go beyond cove in nineteen. Vaccines punditry the message. That boosting might be soon needed if not justified by rowboat robust data could adversely affect the confidence in vaccines undermined messaging. Yeah fell not your role public. How we're already should also carefully consider the consequences for primary vaccination campaigns of endorsing boosters. Only i it vaccines politics. So if they wanna be pundits then we all have a say right. They have no more expertise on on how things will be received with. The minimum. Should be a stupid. And i finally said nothing to challenge the safety profile of boosters. There is no evidence anywhere that the boosters could cause any kind of significant side effects certainly not anything different than the first two shots so like that. That's not based on science at all. Yeah but you last week. Kovacs announced that will have twenty five percent fewer doses to give to the developing world. Then they thought they were going to have and then the..

Janet woodcock fda governor larry hogan ingmar cdc janet woodcock fao maryland fd advisory committee israel america Kovacs
"janet woodcock" Discussed on KLIF 570 AM

KLIF 570 AM

01:52 min | Last month

"janet woodcock" Discussed on KLIF 570 AM

"Need for Covid 19 vaccine booster shots among the general population. That, according to an international group of scientists Here's what concerns me about. This is the way this gets reported, and this happens a lot of times with a lot of, you know any particular subject. The words are available. Evidence does not yet indicate a need for Covid 19 and that has already been turned into. There's no need for a booster shot. It's not the same thing at all. But this is and this is why I always crowing about the need to be specific and clear in our headline. Writers are going to go with it. Exactly right. I've already found a bunch of them. Available. Evidence doesn't yet indicate and all the FDA said, and all the CDC said Dr Janet Woodcock, Uh, the Acting commissioner of the FDA. And Dr Rochelle Walensky, director of the Centers for Disease Control Prevention, recently advised the White House that regulators need more time to review necessary data before approving a covid 19 booster shot plant. It doesn't mean we don't need it. It's frustrating for those of us who are kind of anxious. You know, people in my age group going, okay? I'm ready. Please love it. How much more time do they need? Well, I don't know. And you know, it is like I say, it's frustrating. I just wish people wouldn't would not read into The actual words. This is this is a well done piece as it says it the way it's intended to be heard. Meantime, breakthrough cases of Covid 19 among vaccinated people remain rare. And are generally less serious. Despite the surge of the Delta variant Reports of Covid 19 cases among vaccinated.

Rochelle Walensky Janet Woodcock White House Centers for Disease Control Pr FDA CDC Delta Covid 19 covid 19
"janet woodcock" Discussed on GSMC Health and Wellness Podcast

GSMC Health and Wellness Podcast

12:59 min | Last month

"janet woodcock" Discussed on GSMC Health and Wellness Podcast

"Two thousand nineteen eye shadow contour pallets marketed to girls from clear stores were recalled. The fda found as best those contamination during routine talk monitoring following the incident. The agency called on congress to pass reform cosmetic safety regulations in december of two thousand. Eighteen routers published an investigation claiming johnson and johnson new for decades. The as best does was detected an talcum based baby powder products. Juries have awarded millions of dollars. In high profile cases that linked johnson and johnson baby powder products to cases of ovarian cancer so low mea which is so scary. Because you guys. I still like have baby powder sitting in my household and sometimes i use it as dry shampoo when i run out of and like the fact that this is being put on babies like my mom uses on my siblings in nine when we're babies and just very scary. No you shouldn't be putting all of those harmful chemicals on babies like whites. It makes me upset. Let's continue on. And just keep making me upset right next ingredient we have to avoid is truck lawson try close and as an antibacterial and antimicrobial chemical that can be found in sanitizing hand and body soaps mascara and formerly toothpastes. Funny that is a toothpaste. Because a i have toothpaste Colored fingernails right now. Try close-in hasn't just been linked to liver fibrosis skin. Cancer hormone disruption and the development of bacteria superbugs. It's also just not any more effective than soap and water in april of two thousand nineteen the fda issued a final rule banning otc hand sanitizers from using try close in in today's final regulation. We finalize the fda's previous determination that twenty active ingredients including close-in and benza. Tho- neom chloride are not eligible for evaluation under the fda's otc drug review for us and consumer antiseptic ropes. That's what janet woodcock director of the fda center for drug evaluation and research said in a release at the time the agency added. Fda has not received evidence that trae close and provides a benefit to human health at this time. Fda doesn't have evidence that trek close in an otc consumer and antibacterial soaps and body washes provides any benefit over washing with regular soap and water. Well that's alarming. We might as well. Just wash your hands with soap and water you guys know need to be adding using any ties is a hand soaps with tried close in it. And then lastly the last and final ingredient that we know of to stay away from is silica also known as silicon dioxide. Silica is as an absorbent anti-caking an abrasive agent an everything from oral care products to foundation. Silica is naturally occurring but the kind approved for use in cosmetics is amorphous silica not crystalline silica also known as quartz dust. The science concerning silica is confusing to say the least only one kind of silly does approved for use and cosmetic formulations amorphous silica. So why is crystalline. Silica a known human carcinogen popping up in particles of reparable size and laboratory tests of various bath products and cosmetics. Why some studies suggest that amorphous silica can be contaminated with the crystalline kind. Which would help explain wide still detectable in beauty products. There are environmental concerns as well particularly with the slippery silica. Byproduct found in every beloved. Face primer silicon. Refined silicone are not biodegradable. You guys so again. I know we took a couple of segments to really dedicate You know the time to talk about what ingredients to avoid. But you guys have so important to be aware of these harmful ingredients. And he's just some like. I said out of eighty two thousand ingredients that are put and our hair care products and our makeup in her body. Care eighty two thousand ingredients and fourteen thousand of them have khorasan agenda effects and that are still being used and put in her products that we use on a daily basis should be upset. This is not okay so again. The agreements to avoid. I'm a list of mount for yom parabens fragrances. Iseo oscillated agents for me. Hide refined petroleum hydro coin. Tauk trike loosen silica oxy ben zone and aluminum compounds again. They'll just of what we know of right now so now that we kind of wrapped up. You know what ingredients to avoid. Let's talk about what. Actually what does clean consists of. What is it mean. Clean organic cruelty feet when it comes to beauty products. The fda has yet to regulate how brands can use these words again. These are just marketing words. Definitions are subjective and often change from company to company package. Two package mickan. It nearly impossible to navigate or decipher the truth from greenwashing. So hopefully you know this segment. We're able to break it down. You know the most common buzzwords for some much needed clarity. So what does clean mean safer. People and the planet clean means that a beauty products should have considered human and environmental health using a non-toxic element as a baseline and plant based ingredients for active results. Much like eating clean rejects the idea of processed foods and focuses on nourishing plant based produce the delivers all the vitamins and antioxidants needed for a healthy immune and digestive system. The same is true for clean skincare. So that's im- simplest terms what clean means so. What does green mean. The word green should mean that the product is no harm to the environment. For instance a reef. Safe sunscreen with biodegradable. Packaging would be labeled green however this is a very wishy washy term with no true definition and is usually used as an umbrella for any product that claims to protect the planet's resources. So now what does organic mean personal care. Products that are certified to be at least ninety five percent. Organic will bear an official. Usda organic seal products bearing the usda organic seal must also comply with handling and manufacturing specifications and the use of genetically modified organisms is prohibited in an effort to avoid pesticides. The clean beauty industry has begun to use organic plant based ingredients and products wherever possible however the certification is expensive so many smaller bands will independently label ingredients that are organic on packaging despite not carrying an official seal. Did you guys know this. Because i did it. What so because expensive to become certified certified organic. You're gonna do it you know under the table. I own like that. There's a lot of things about all the information. I'm spewing out today that i don't like so now what is nontoxic mean in simplistic terms. Water and oxygen can be toxic in the wrong dose so when a beauty product is labelled nontoxic a likely mean that the ingredients have not been shown to cause adverse health effects at the levels found inside the formula and for the intended use. This is true every beauty product. Can you know currently sold in the united states in the clean beauty. Space nontoxic means that a product should include any ingredient. That's been deemed toxic. Any dose by third party resource like the european union or environmental working group so now what does sustainable mean. Sustainable goes hand in hand with green. It means that the ingredients on the inside of the package including how those ingredients were source and the packaging itself should not be harmful to the planet when you use any product. The ingredients go down the drain and into the water system which thanks to. Exfoliating micro beads and preservatives. Like be h. a. is causing marine environment health crisis likewise many conventional beauty products are made from petroleum jelly and our package and plastic both created from the oil industry. Truly sustainable ingredients are those that are ethically source and proven to be safe for the environment with sustainable or no waste. Packaging being defined as glass packaging. Bow degradable packaging post consumer recycled packaging or the ability to recycle empty bottles appropriately through a tariff cycle program and moving on what is vegan mean. What does that term mean. A beauty product is vegan if it doesn't contain any animal byproducts or ingredients source from animals common non vegan ingredients found in clean beauty products include beeswax honey leno lynn and tallow many people associate vegan with clean. But that is not the case. Those terms are not synonymous. A product can be vegan and still contain chemical ingredients of concern. Fbi and leslie. What does cruelty free mean. A beauty product is cruelty free if it has not been tested on animals anywhere along the manufacturing lying or before being sold it can also mean that any animal derived ingredients were not extracted at the expense of in animal's welfare. Like natural fiber maker brushes. A beauty product can be cruelty free but not vegan and vice versa. So i hope this clarifies a little bit more for you guys. You know the buzz on these buzzwords. Because i know a lot of these makeup brands and just personal care product branches. Throw these terms out and like we don't really understand what it means to be organic. Or nontoxic or sustainable. So i really hope this. Many dictionary a podcast. Now right now was helpful for you. Guys so burnett jump into a really quick break right now and when we come back more on clean beauty. Are you tired of the same old news. Are you stick up. The seemingly. Endless political spin negatively the mc. America's still beautiful. Podcast is a weekly news. Podcast covering all the top positive and outliving news stories. We cover stories that will inspire uplift and remind you of the good in the world tune in to the golden state media concepts. America's still beautiful podcast to get all the great and positive news stories of today. Download the ncaa. America's deal beautiful podcast on. Itunes stitcher soundcloud. Google play or any podcast. Just tight.

fda johnson fibrosis skin benza janet woodcock fda center for drug evaluation mickan ovarian cancer Usda congress european union or environmenta Cancer leno lynn America leslie Fbi burnett ncaa Google
"janet woodcock" Discussed on Mark Bell's Power Project

Mark Bell's Power Project

02:08 min | Last month

"janet woodcock" Discussed on Mark Bell's Power Project

"Put out put up a post yesterday that got a ton of heat. But it's kind of awesome. I like it. I like the heat. So i put up a post. That said that Dr janet woodcock to real name. She's the same person that was in charge. She was in charge for a year when like oxycontin was approved. Now that doesn't mean anything necessarily. Fda approved a lot of things. The point i was making is like look at where oxycontin went sideways. That went look at the alzheimer drug. That dr janet woodcock was in charge of Pushing through when everybody said this is gonna kill a lot of people and she's still pushed it through. Look at this so-called not even a vaccine but this thing that they have out now this medication. what is that going to do. We don't know for for people. It's just is ridiculous for me to say that it's going to be bad as it is for people saying that's gonna be good It's just like i don't know either. I don't know if it's going to be. I think that people are under the illusion that the vaccine is going to prevent them from getting sick. My best friend in the entire could prevent you from getting sick or my best friend in the entire world called me yesterday. He is the head of one of the divisions of pfizer. And he basically said you have. This vaccine worked for some people. It doesn't work for other people. People still get sick other. He's like it should just be a choice You know and this is a guy that works for the company. He's like it's stupid. It's not been shown like yeah it's been shown to be effective But it has been shown to prevent it or prevent the spread of it or prevent this and that and so like. We've seen that. Why not i think there needs to be more mesic more messaging around. You're probably going to get. You're probably going to get sick. Yeah that and that's okay. You're probably gonna get it and if even if you're vaccinated you're probably gonna get a you just might get it to a little bit lesser degree. I think that's healthy. I think that's i mean i don't know what the other option is just to stay inside and not do anything. Even i'm not. I'm not anti vaccine. I'm not against the vaccine. I'm not. I am against it for myself because i have autoimmune conditions that i'm still trying to figure out.

Dr janet woodcock dr janet woodcock alzheimer Fda pfizer
"janet woodcock" Discussed on 5 Things

5 Things

03:13 min | Last month

"janet woodcock" Discussed on 5 Things

"People ages sixteen and older the vaccine continues to be available under emergency use authorization for individuals. Twelve through fifteen years of age and to provide a third dose for certain immuno-compromised individual. That's acting fda. Commissioner dr janet woodcock the move could open the door for more employers to require their workers get vaccinated against the virus after the announcement president. Joe biden urged private companies to require vaccination. He already did the same for federal employees last month. Some companies have required. Vaccinations already but many others were holding off waiting for full approval instead of the emergency use authorization that vaccines have so far been administered under in the us with new requirements and the delta variants spreading throughout the country. Vaccinations have ramped up. In recent weeks in the last seven days six million shots were administered around the country a month and a half high and many lagging states particularly in the deep south have seen rising rates. The modern a- and johnson and johnson vaccines are still available wonder emergency use authorization. Moderna filed its request for full approval after pfizer and johnson and johnson is expected to do the same in the coming months. Sixty point eight percent of the country is now at least partially vaccinated with fifty one point. Five percent fully vaccinated is in the sports again. Shift attention back to tokyo on tuesday for the start of the paralympic games and just like the olympics which wrapped up there earlier this month there are restrictions because of the pandemic but some fans will be in attendance as japan is leading. Some students watch competitions this year. More than four thousand athletes representing at least one hundred thirty four countries will compete in five hundred forty different events that includes two hundred forty athletes representing the united states. One of them swimmer anesthesia pavonis. She had to relearn how to swim after losing her eyesight coach. More dannon helped her along as told in this episode of sports kind. He was only coached. That would take me on and that life wanted to train the blind girl on faith in me and he taught me how to swim all over again. I lost position which was amazing. And i'm so thankful for him didn't really know what i was getting myself into. Have some good karma and try something nice you actually put black-out goggles on himself and tried to swim the way that iceland i hit my hand a hit my head i had people tapping me on each side of the wall so i have this whole. With whom little. On the get a little over the top of the head. And i take my show for more on the paralympics had to usa. Today sports pumpkin spice is back. Starbucks is bringing back. It's seasonal pumpkin. spice lot. say on tuesday. The drink is associated with the full season. And even though. It's still august.

Commissioner dr janet woodcock johnson Joe biden Moderna fda paralympic games pfizer usa tokyo olympics dannon japan iceland paralympics Starbucks
"janet woodcock" Discussed on The Patriot AM 1150

The Patriot AM 1150

01:52 min | Last month

"janet woodcock" Discussed on The Patriot AM 1150

"Many out as quickly as possible. When Lisa Brady Fox News that's the Pentagon's goal in Afghanistan, the Taliban warns of consequences if the US withdrawal deadline of August 31st isn't met, but that deadline was set before the chaotic evacuation Now underway. Foxes Rachel Sutherland has this life. Lisa U. S troops used a rotary wing airlift to rescue Americans trapped outside Has E. Karzai International airport. Pentagon spokesman John Kirby says commanders are making decisions moment by moment on the ground can move. Forces can employ forces and assets as they see fit to do that and again on any given day. That could change. Kirby says. Several 1000 US citizens have been evacuated, but he would not give a specific number, saying it's very fluid and changes by the hour. Around. 16,000 people have been flown out of Afghanistan over the past 24 hours. Lisa thanks, Rachel Summits thirties spent 1000 evacuated in just over a week. Fighters. Covid vaccine now has full FDA approval instead of just emergency use authorization. This is an unprecedented timeline, given the volume of review and the meticulous manner in which it was done. But acting FDA Chief Janet Woodcock says the effort to move quickly did not sacrifice scientific standards or the integrity of the Process. That vaccine will now have the brand name community. Full approval is for ages. 16 and up, But emergency use is still authorized for ages. 12 to 15, the White House hoping for full approval of the Moderna and Johnson and Johnson vaccines soon President Biden scheduled to speak later this hour. Capitol police just out with the results of an internal probe into the shooting death of a California woman, Ashley Babbitt, during the capital riot, the probe finds the officers conduct was lawful and part of the effort to save members of Congress and staff from serious injury or even death as rioters breached the capital. Prosecutors.

Lisa Brady Ashley Babbitt John Kirby August 31st Congress Kirby Lisa 1000 White House Rachel Sutherland Taliban Pentagon Janet Woodcock Afghanistan thirties FDA Fox News 12 California 15
"janet woodcock" Discussed on KTLK 1130 AM

KTLK 1130 AM

01:50 min | Last month

"janet woodcock" Discussed on KTLK 1130 AM

"Stand as the Taliban warns of consequences if the US withdrawal deadline of August 31st isn't met, but that deadline was said before the chaotic evacuation now underway. Foxes Rachel Sutherland has this live. Lisa. US troops use a rotary wing airlift to rescue Americans. Pentagon spokesman John Kirby says commanders are making decisions moment by moment on the ground can move. Forces can employ forces and assets as they see fit to do that and again on any given day. That could change. Kirby says. Several 1000 US citizens have been evacuated, but he would not give a specific number, saying it's very fluid and changes by the hour. Around. 16,000 people have been flown out of Afghanistan over the past 24 hours. Lisa thanks, Rachel Summits thirties spent 1000 evacuated in just over a week. Fighters. Covid vaccine now has full FDA approval instead of just emergency use authorization. This is an unprecedented timeline, given the volume of review and the meticulous manner in which it was done. But acting FDA Chief Janet Woodcock says the effort to move quickly did not sacrifice scientific standards or the integrity of the Process. That vaccine will now have the brand name community. Full approval is for ages. 16 and up, But emergency use is still authorized for ages. 12 to 15, the White House hoping for full approval of the Moderna and Johnson and Johnson vaccines soon President Biden scheduled to speak later this hour. Capitol police just out with the results of an internal probe into the shooting death of a California woman, Ashley Babbitt. During the capital riot. The probe finds the officers conduct was lawful and part of the effort to save members of Congress and staff from serious injury or even death as rioters breached the capital. Prosecutors have already said the officer won't face charges. America's.

John Kirby August 31st Afghanistan Ashley Babbitt Kirby Congress Rachel Sutherland White House Janet Woodcock 1000 Pentagon Taliban Lisa 15 FDA thirties California Foxes America Rachel Summits
"janet woodcock" Discussed on WCPT 820

WCPT 820

01:31 min | Last month

"janet woodcock" Discussed on WCPT 820

"Commissioner, Dr Janet Woodcock says she hopes final approval of the vaccine will convince the skeptics that is a good time to get vaccinated. There will soon be mandatory vaccinations in the military. The Pentagon says spokesman John Kirby is preparing to make the Covid 19 vaccine mandatory in the military. The health of the force is as always, of our military and civilian employees, families and communities is a top priority. That's what's important to remind everyone that these efforts to ensure the safety of our service members and promote the readiness of our force, not to mention the health and safety of the communities around the country in which we live. While he didn't give a timeline, Kirby says Pentagon officials are preparing to issue guidance to require vaccinations. Now that the fighter vaccine has been given full approval. I'm Shelley Antler, the military reported its biggest day of airlift out of Afghanistan by far But the Taliban signal they might shut down the evacuation. Major General Hank Taylor's with the Joint Chiefs of Staff. Our mission remained focused on ensuring a steady flow evacuees out of Kabul to the intermediate staging bases and safe havens. A Taliban spokesman says the August 31st deadline for the US to leave Afghanistan is a red line that the U. S must not cross. This is Andrew Cuomo's last day on the job as governor of New York. He resigned rather than face the possibility of impeachment over sexual harassment allegations There was a political and media stampede. But the truth will.

Andrew Cuomo John Kirby Shelley Antler Janet Woodcock Kirby August 31st Pentagon Afghanistan Kabul Hank Taylor Taliban Joint Chiefs of Staff New York US Major General U. S Covid 19
US Regulators Give Full Approval to Pfizer COVID-19 Vaccine

AP News Radio

00:47 sec | Last month

US Regulators Give Full Approval to Pfizer COVID-19 Vaccine

"The food and drug administration is given full approval to Pfizer's covert nineteen vaccine acting FDA commissioner Janet woodcock says the public can be in her words very confident the Fizer vaccine meets high standards for safety effectiveness in manufacturing quality according to Pfizer the U. S. becomes the first country to fully approve it shot the FDA's approval may spur more vaccine mandates by companies universities and local governments a recent poll by the Associated Press in a R. C. center for public affairs research shows nearly six in ten Americans favor requiring people to be fully vaccinated to travel on airplanes or attend crowded public events Mike Hampton Washington

Pfizer FDA Janet Woodcock U. S. R. C. Center For Public Affair The Associated Press Mike Hampton Washington
"janet woodcock" Discussed on WBZ NewsRadio 1030

WBZ NewsRadio 1030

02:07 min | 3 months ago

"janet woodcock" Discussed on WBZ NewsRadio 1030

"As Or two and we're still in certain areas at 45 Kaminsky says They are searching stairwells and bedrooms in hopes of recovering more victims. Lionel Moise ABC NEWS Miami 6 19 Some new developments tonight on that controversial drug that's meant to treat Alzheimer's disease. We've been telling you about this, the head of the FDA now calling for an internal probe into how exactly that drug was approved. The inquiry pertains to communications between staff at the FDA and drug company Biogen responsible for the drug at Helm used for the treatment of Alzheimer's disease. Janet Woodcock, acting commissioner of the FDA, wrote to the inspector general about concerns raised during the approval process concerns she says, could undermine the public's confidence in the FDA s decision making. She's asking the inspector general to conduct an independent investigation until alleged communications, she says are inconsistent with FDA policies and procedures. I could watch him. ABC News Washington and more negotiations Today in Worcester is the strikeout at ST Vincent Hospital involving the nurses hits 124 Days, Reps from Tenet Healthcare, the parent company, and those for the nurses meeting in person today for the first time in 15 months, demands of nurses, including staffing and patient care improvements right now, this strike is the longest by nurses across the country in more than 10 years. Also this evening. We're learning that Pope Francis is staying in the hospital for at least a few more days. Let's get the update from ABC is Megan Williams. She's in Rome, the Vatican said on Friday. Pope Francis continues to recover from surgery where he had part of his colon removed. Francis underwent 23 hours of scheduled operation last Sunday after reciting the Angelus prayer overlooking ST Peter's Square. The latest Vatican statement on the pope's health says he is walking around in the hallways of the Gemelli hospital here in Rome. And is working and reading. On Thursday, Francis celebrated Mass with those caring for him at the chapel of the private quarters of the hospital Wednesday night. He had a slight temperature, which passed quickly, says the Vatican. Megan Williams. ABC News Rome 6 21, Several traffic trouble south of town. We'll check in with Mike King coming up in about two minutes..

Mike King Janet Woodcock Lionel Moise Megan Williams Francis 23 hours Friday Wednesday night Worcester Thursday Rome Biogen Tenet Healthcare ABC 124 Days 15 months ABC News last Sunday ST Peter's Square today
FDA Calls for Investigation Into Alzheimer's Drug Approval Process

News and Perspective with Taylor Van Cise

00:31 sec | 3 months ago

FDA Calls for Investigation Into Alzheimer's Drug Approval Process

"The approval of a controversial new Alzheimer's drug. In a letter sent to the health and Human Services Inspector General Janet Woodcock asks for an independent review into the interactions between drugmaker Biogen representatives at the FDA Woodcock alleging that there may have been communication between the FDA and Biogen during the review process that goes against FDA policy. Biogen's new Alzheimer's drug received FDA approval in early June despite an advisory committee previously questioning its efficacy. ABC News is next get more out of

Alzheimer's Drug Health And Human Services Insp Biogen Janet Woodcock FDA Abc News
FDA Head Calls for Inquiry Into Alzheimer's Drug Review

AP News Radio

00:42 sec | 3 months ago

FDA Head Calls for Inquiry Into Alzheimer's Drug Review

"The FDA wants an independent watchdog to take a closer look at the decision making behind the conditional approval of a new Alzheimer's drugs that can reduce brain plaque but hasn't been proven to reverse the disease the acting head of the food and drug administration Dr Janet woodcock is calling for a government investigation into the contacts between your agency's drug reviewers and the maker of a controversial new else Hymers drug ad you help the announcement made via Twitter comes just a day after the FDA took the unusual step of scaling back prescribing information on the drug last month the health news site stat reported on it usually close collaboration between a top executive and the FDA's lead reviewer for Alzheimer's drugs Biogen has pledged to cooperate with the inquiry Jennifer king Washington

Alzheimer's FDA Dr Janet Woodcock Hymers Twitter Biogen Jennifer King Washington
"janet woodcock" Discussed on Newsradio 700 WLW

Newsradio 700 WLW

01:39 min | 3 months ago

"janet woodcock" Discussed on Newsradio 700 WLW

"Report. I'm Matt Reese. Breaking now A new drug for Alzheimer's patients may be getting a second look. The head of the Food and Drug Administration is not comfortable with how it was approved. And once the process investigated. Shares on the drugs maker Biogen has taken a hit falling about 3%. Today, the inquiry pertains the communications between staff at the FDA and drug company Biogen responsible for the drug at the helm used for the treatment of Alzheimer's, too. These. Janet Woodcock, acting commissioner of the FDA, wrote to the inspector general about concerns raised during the approval process. Concerns she says, could undermine the public's confidence in the FDA has decision making. She's asking the inspector general to conduct an independent investigation into alleged communications, she says are inconsistent with FDA policies and procedures. Like a jockey. ABC NEWS Washington Let's check you drive home as we head into the weekend, the latest traffic and whether together from the UC health Traffic Center. UC Health is the region's leader in cancer and Neurosciences. This is science and in science lives. Hope allow for plenty of extra time on your drive this afternoon as there is heavier than normal volume on the highways. There is a broken down on South 75 past Galbreath on the right shoulder and Springfield Pike is blocked in both directions between Glendale, Milford and Congress Avenue in Woodlawn. That's due to some downed wires. You can try using Glendale Road in Oak Street as your detour delays at the Brent Spence Bridge. Th beyond 35 minutes from Mitchell and North Beyond 12 minutes approaching Kyle's Lane. I'm Rob Williams news.

Janet Woodcock Matt Reese Glendale Glendale Road Food and Drug Administration UC Health Brent Spence Bridge Springfield Pike UC health Traffic Center Congress Avenue Rob Williams Biogen Today South 75 35 minutes ABC NEWS Milford Oak Street Mitchell FDA
"janet woodcock" Discussed on The Mighty Oaks Podcast

The Mighty Oaks Podcast

08:22 min | 3 months ago

"janet woodcock" Discussed on The Mighty Oaks Podcast

"I did capitalize on that market. Put together portfolios of reynolds. I ended up teaming up with the group that was doing it on a much. Bigger scale We took that company. Publicly traded into a re real estate investment. Trust just a focusing on mostly single family homes. So i was running my company. I was the ceo of that read. And i was helping a just a colleague of mine market a property in in mexico and it was a an old resort property in in amongst we short as it was we were not getting great offers and so thinking outside of the box and being that i am from arizona which is a border town to mexico are or state in mexico there. Is this term. That was really starting to rise in and it was medical tourism. So what i was doing. A by just by way of marketing was starting to market this property to medical tourism type doctors and physicians companies so i was marketing to Plastic surgeons dentists and a vision companies Anyways the point is is the essential company had occasion to needs that. Hey look at you know. We think that this property actually might be right for us. We're looking to take our science out of the laboratory and put it into action in actually treat people and help people and you know other than what i had seen on the news. That was my first really reduction to stem cell and deep introduction into what it really can do and how many ailments it can treat and how many lives at can potentially save so my mind was blown. You know pretty quickly. And that started the trajectory of me transitioning into forming bio accelerator. We talk about medical tourism. So why a two things one. Why do people tour. Outside the united states to go get medical treatments done me. I think a lot of people with a will get something done in. The united states is if i go to mexico. It's is it as safe columbia. Is it as safe. That's a question. I think a lot of people would have. I'm sure you have a really good answer for that. I hope you do and in a in a you know what are their restrictions. United states that keeps people from being able to do those treatments. Here that's real questions there yet so much to impact us with those two questions. So you know what i would say just From a brief comment perspective because of what you said about the safety issue medical tourism kind of started. Its its popularity with things that are known to be safe so people were going across the border to get glasses able going across the border to a you know to do dental work. That was you know. Pretty standard and safe to do in a place like mexico However when you start getting to the higher level science. They're very few countries. That have the wherewithal in the knowledge to be able to implement. Things like stem cell therapy. So that's one of the reasons. We went to columbia because it's an incredible medical system. It's extremely safe For those of us that know travel overseas quite a bit at have had medical procedures in places like colombia. I i don't even get dream in the us anymore. But so the the safety is certainly in issue in some places circ not columbia but unfortunately in the us fortunately and unfortunately we have a great organization multiple organizations like the fda But when we're looking at the fda and it's a fantastic organization it's a it's under fantastic leadership and they are here to protect us the inert and people and they do a great job of that I would say that. Unfortunately there are a little bit behind in the way that they have taken a real serious look at stem cell therapy and they all seem to be behind it in the conferences that we go to the the The contact we have with scott gottlieb. Janet woodcock commissioner They all seem to be pretty knowledgeable in behind it But some of the the regulations and certainly some of the language in those regulations are antiquated. They still haven't defined things like What they consider to be minimal manipulation of cellular and so that leads companies like ours to the. They don't wanna play in the gray area because there are some companies that are doing that in the united states using very low level science. Or but we know with our company and with You know global research. The highest level science is producing great results so we had to go offshore for to produce and get our patients. The awful outcomes without going down a rabbit hole on conspiracy. Theories is a. I would love to do that. Then we can do that on a conspiracy. I mean is is there a. Is there like a big form. Push back to keep stem. Saudi united states in order to keep healthy. I mean is there. is that a reality. Or is that just a conspiracy. That people like me. Think if i wasn't running a a ceo of a healthcare company and we talking privately. I i might go a little bit deeper. But i will tell you this. Look what i typically do. When i when i have these type of conversations i like to turn it back to maybe your audience or question back to the fda or or organizations that may have an interest in keeping people. Sick i. I'll tell you this. I traveled to colombia. When i'm here for just a few weeks. My energy levels improve. I shed a couple pounds. I usually lose about five pounds in time in state of about three or four weeks doing no Exercise nothing changing other than the food that. I consume your They you know. They don't have a lot of preservatives here. They don't they don't feed their you know their their cows chickens hormones The you know the it just it just a cleaner way of living so starting with food i would say that. That's a big thing. And then you know one of the things that stem cell therapy does very very well. As it helps modulate the immune system it helps reduce inflammation it helps. Combat things like autoimmune disease than there many many many many of those And right now pharmaceuticals are the only thing that treat some of those and they only treat the symptoms. They don't get to the suspended group. So i would say that. There's many big big big money players big powerful organizations that have interested slowing down. Stem cell fisher. Yeah big lot veins dollars to be lost if you actually. He'll be i the reason i asked that. So many people i know. We're going to get into stem cell and what it does and what would it actually does. But i've just seen so many testimonies of people who are just deathbed. Ill injured in recover from stem cell on. Why is what's the what's the blockade. What's t they that. Keeps it from happening here. The united states which is supposed to be one of the greatest countries in the world. You know and i believe it is but but why can't it happen ear. And that's my conspiracy baynes dollars to be lost and so it's going to be a fight for people like you to bring her will look. There's another piece of that to you because we know it can happen it. Meaning that these regulations can be fasttrack. We've just seen it with covert nineteen. There are many many many vaccines that have been fast tracked through the process. There even clinical trials and staint sell. My company is doing one here in columbia But there are many companies that were even associated with them from an arms length that have had the fda approved clinical trials for covert not with sunshine. Cell therapy so we know they can push it through. And there is no debate in the fda or in the scientific community. Whether or not stem cell is safe. Which is the biggest part of fast-tracking. So if you know they're safe rocket up really hurt people. I mean the side effects are so minimal than why can't we push this through and help.

mexico united states columbia fda scott gottlieb Janet woodcock reynolds colombia circ arizona Saudi autoimmune disease fisher baynes
"janet woodcock" Discussed on WHAS 840 AM

WHAS 840 AM

01:36 min | 5 months ago

"janet woodcock" Discussed on WHAS 840 AM

"Is a key step in fighting covert 19 trying to get the herd going. I guess you're Baylor infectious disease expert, Dr Peter Hotez. Says This is important. We get the Children ready to go back to school in the fall. Is that Let's try that again. Ah Ah And we we go, Peter. What do you think, Doc? That's going to be our ticket to also vaccinating our way out of this epidemic If we can get police three quarters of the U. S population vaccinated, so the FDA saying visors Vaccine is ready to roll here. This is the Visor Vaccine, and Commissioner Janet Woodcock. Saying Vaccinating younger people will allow the U. S to return to normal signals. Hope you know, I'm I'm wondering how many parents are going to be willing to do this. I suspect My first jump. Scotty. When I was thinking about this would be to go and call the pediatrician and talkto talk it over. It's a no brainer for us. My son's going. This is I get time away from work to go take there you have. It wouldn't even think twice about it. He's older, though he's 16. Still gonna vaccinate if you were younger, Okay? Yeah, I wouldn't have a problem with it. It's gonna be you know, one of those interesting and decisions, But I do think it'll help fight the vaccine. They've been doing some trials on that. And so I mean, fight the Disease. I should take 6 49. We're about 10 minutes, but it's out from seven. Scott Fitzgerald has to check his forthcoming away. Next course. Will Clark is joining us top of the hour for the your headlines and your news coming up. We're gonna talk more about that authorization from Erica Thirsty. ABC News has more details Force.

Erica Thirsty Janet Woodcock Scott Fitzgerald Peter Will Clark Peter Hotez 16 Scotty twice ABC News FDA seven U. S about 10 minutes Baylor first jump one 19 6 49
"janet woodcock" Discussed on WBZ NewsRadio 1030

WBZ NewsRadio 1030

03:25 min | 5 months ago

"janet woodcock" Discussed on WBZ NewsRadio 1030

"Janet Woodcock. Today's actions, she says, allows for a younger population to be protected from covert, bringing us closer to returning to a sense of normalcy and unending off the pandemic. The Biden administration says it will look to protect trans rights by repealing a trump era policy. The Department of Health and Human Services Monday said it will roll back a Trump administration policy that tried to narrow the legal protections against Incrimination in health care by issuing rules to finding sex is gender assigned at birth. HHS secretary Heavier But Sarah said in a statement. Quote. Fear of discrimination can lead individuals to forego care which can have serious negative health consequences, Miss Sarah said. This action today puts HHS in line with the 63 Supreme Court decision last year that established that federal laws against sex discrimination on the job also protect gay and transgender people. Karen Travers. ABC NEWS Washington The World Health Organization says the current coronavirus hot spot of India's also dealing with a type of Kovar that may be easier to spread. Maria Van Kirk Cove is the wh Ose technical lead for covert 19 and says they're trying to learn more about the various, even though there is increased transmissibility demonstrated by some preliminary studies. We need much more information about this virus variant in this lineage. Meantime, ABC is Victor Oquendo is at Miami's airport, one of several airports to offer shots to travelers in an attempt to increase vaccinations as demand for shot slides as vaccine demand is declining for adults, the US now just below two million shots a day. Down nearly 40%. In the last month, Louisiana and Mississippi turning down vaccines on Lee, one third of adults there are vaccinated. All eyes are now on vaccines and Children. The FDA expected to authorize 12 to 15 year Old Supervisors vaccine as soon as today and again, the FDA has approved that Fizer vaccine for adolescents starting today. It adds to the visor beyond Tec vaccine, which already had been approved for those 16 and older and speaking of vaccines. It's easier than ever to get a shot in Massachusetts walking vaccinations. Now available at the state's mass vax sites. Gillette Stadium was the last to require appointments. The company that runs that site announced today. They are also now taking walk. Ins. Brockton Planning a day of tribute later this month, too marvelous. Marvin Hagler boxing. Great God has started the city and died back in March. Growing up in a city like Brockton. You see a lot of good you see a lot of bad and to have someone from your city where you grew up, achieve. The things that he achieved on the world stage was The inspiring and it should inspire kids and Brockton Today Dave Wedge is a Brockton contractor now helping the city plan a memorial to the boxing legend on what would have been a 67th birthday Sunday. The 23rd we have also, it's agreed people coming in. Bernard Hopkins is coming. Who is AH, world champion Stephen A. Smith from ESPN will be there It comes after Governor Baker declared May 23rd Marvin Hagler Day in the state? One of the reasons why Brockton is called the city of champions, So I think to celebrate. Marvelous Marvin Hagler is life. At Marciano Stadium is really a fitting tribute in Brockton. Madison Rogers WBZ Boston's news radio 5 20 Local guerilla is going viral. For her motherly instincts. WBC's Max sure has the story. It was five minutes of pure cute nous. A.

Janet Woodcock Karen Travers Stephen A. Smith Bernard Hopkins Maria Van Kirk Cove Dave Wedge 12 Marvin Hagler Massachusetts 16 FDA Madison Rogers HHS Gillette Stadium Sarah May 23rd ABC Marciano Stadium last year ESPN
FDA Moves to Ban Menthol Cigarettes and Flavored Tobacco Products

First Light

02:12 min | 6 months ago

FDA Moves to Ban Menthol Cigarettes and Flavored Tobacco Products

"Light up plans are underway by the Food and Drug Administration to ban menthol flavored cigarettes and all flavored cigars more from Kathy Foster. According to the Centers for Disease Control and Prevention. Smoking is the leading cause of preventable death in the U. S. And One study, conducted by the Food and Drug Administration found that a ban on mental cigarettes could potentially save more than 630,000 lives by 2050 acting FDA Commissioner Janet Woodcock says Because of that, the next year the FDA plans to work toward issuing tobacco products standards that will be in mental and cigarettes. And ban all flavors, including mental in cigars, Woodcock says banning mental the last allowable flavor and banning all flavors in cigars will help save lives, adding methanol acts like a drug when smoked aesthetic properties and qualities that help mask the harshness and irritation of tobacco smoke. Flavored tobacco, including flavors found in some cigars and cigarillos make smoking more appealing by reducing initial aversive responses, according to the latest available statistics released by the CDC. More than a third of all cigarettes sold in the United States were mental flavored. Studies also show that methanol can especially believe young people to become regular smokers, since the flavors may make it easier for beginners to try tobacco. Furthermore, FDA tobacco products Director Mitch Zeller says this Right. The tremendous progress made getting people to stop smoking over the past 55 years. The progress has not been experienced by everyone. Equally. 85% of all black smokers use mental cigarettes. Compared to just 30% of white smokers. And while we've seen declines and mental cigarette use among non Hispanic white use, we have not seen the same declines. And youth from communities of color. The potential band would only apply to keep the products off the market but would not apply to individual possession or use the tobacco industry and its allies are making it clear they plan to put up a challenge. And while the FDA hopes to have the band in place within the next year, it must first go through at number of hurdles, including legal challenges, public comment and even the White House

FDA Kathy Foster Janet Woodcock Centers For Disease Control An Woodcock U. Mitch Zeller United States White House
U.S. Lifts Pause on J&J's Covid Vaccine

The Afternoon News with Kitty O'Neal

01:01 min | 6 months ago

U.S. Lifts Pause on J&J's Covid Vaccine

"On Johnson and Johnson's covert 19 vaccine. Just hours after a CDC recommendations for an extensive review of the available data, the FDA and CDC are lifting the recommended pause on the Johnson and Johnson or Jenson Covert 19 vaccine. That's acting commissioner Dr Janet Woodcock, ABC Stevo Since Sami is that CDC headquarters, health authorities put a pause on using the vaccine after six women came down with severe blood clots about two weeks after getting the shot the CDC shares that there are now 15 of these cases, most of them with severe blood clots near the brain. All of them are women between 18 and 59 years old. Three of them died and seven are still hospitalized. But the experts underlying that thieves are out of eight million Americans who've gotten the shot with no serious complications. Those who received the shot will be told to watch for symptoms, including severe headache or leg pain, which could be signs of blood clots. Vice President Harris hit

CDC Johnson Jenson Covert Dr Janet Woodcock Stevo Since Sami FDA ABC Headache Vice President Harris
Johnson & Johnson COVID-19 Vaccine: FDA, CDC Call for 'Pause' in Distribution

Colorado's Morning News with April Zesbaugh and Marty Lenz

00:19 sec | 6 months ago

Johnson & Johnson COVID-19 Vaccine: FDA, CDC Call for 'Pause' in Distribution

"Remain recommending an immediate pause in the distribution of the Johnson and Johnson vaccine due to a handful of blood clot concerns cases of a rare and severe type of blood clot following vaccine administration. The acting FDA Commissioner Janet Woodcock says the federal health agencies want more time to review the data. The World Health

Johnson Janet Woodcock FDA World Health
Johnson & Johnson's Covid-19 vaccine gets the nod from CDC

NPR News Now

01:03 min | 8 months ago

Johnson & Johnson's Covid-19 vaccine gets the nod from CDC

"A d. c. advisory panel today unanimously endorsed johnson and johnson's single-dose covid nineteen vaccine a day after the fda approved it for emergency. Use the reviewers calling. It's safe and effective. It's now the third authorized covid vaccine in the us and npr's amy held reports doses are now being shipped out three point. Nine million doses of the johnson and johnson vaccine are ready to be distributed by the end of june. It's one hundred million combined with the other two authorized vaccines more than enough to cover the entire adult population. This summer. johnson and johnson's overall efficacy rate of sixty. Six percent is lower than pfizer. And maderna's still people should take the vaccine and they are able to act dr janet woodcock acting. Fda commissioner says comparing the vaccine is difficult not not eating head to head trial in its own clinical trial one month after vaccination johnson and johnson shot was found to provide complete protection against hospitalization and

Johnson FDA Maderna NPR AMY Dr Janet Woodcock Pfizer United States
Johnson & Johnson's shot authorized by F.D.A.

The Dana Show

00:22 sec | 8 months ago

Johnson & Johnson's shot authorized by F.D.A.

"Today. The Johnson and Johnson single dose covert vaccine just approved for emergency quick use by the Food and Drug Administration Acting commissioner Dr Janet Woodcock Jenson Open 19 vaccine known and potential benefits outweigh its known a potential risk with clear evidence that the vaccine may be effective in preventing covert 19 3

Johnson Dr Janet Woodcock Jenson Open Food And Drug Administration
Johnson & Johnson's Covid-19 vaccine gets emergency use authorization from FDA

Purity Products

00:27 sec | 8 months ago

Johnson & Johnson's Covid-19 vaccine gets emergency use authorization from FDA

"Virus vaccine. This one from Johnson and Johnson gets the final go ahead from the FDA. With the FDA authorization and falling review by the advisory Committee on Immunization practices and with the endorsement by the director of the CDC. This additional vaccine will soon be distributed throughout the country by our federal partners who oversee vaccine allocation and distribution. Acting FDA Commissioner Dr Janet Woodcock

FDA Johnson Advisory Committee On Immuniza CDC Dr Janet Woodcock
FDA grants emergency authorization to Johnson & Johnson vaccine

The Splendid Table

00:42 sec | 8 months ago

FDA grants emergency authorization to Johnson & Johnson vaccine

"A third vaccine against covert 19. The Food and Drug Administration has granted emergency use authorization authorization to Johnson's and Johnson's shot to change a single dose vaccine. Has a lower efficacy rate and the Fizer and Moderna shots but acting FDA Commissioner Janet Woodcock seeking to reassure Americans about it each of these vaccines Will be effective will prevent hospitalization death and should be used. President Biden issued a statement saying the country is moving in the right direction. But he says Americans should not let their guard down. The pandemic has led to more than 510,000 deaths in the U. S. Some

Fizer Food And Drug Administration Janet Woodcock Johnson President Biden U.
FDA advisers recommend J&J vaccine for emergency authorization

WTOP 24 Hour News

02:19 min | 8 months ago

FDA advisers recommend J&J vaccine for emergency authorization

"Amid this new warning from President Biden. There's been another significant step forward for the nation's covert effort. An FDA advisory committee endorsing Johnson and Johnson's covert shot and, according to multiple reports of CDC expects the FDA to grant emergency use authorization tomorrow. CNN Health editor Maggie Fox joining our own Sean Anderson and Hilary Howard earlier to talk about This endorsement was made said that it was a pretty easy decision for them. They said that the data clearly showed that this vaccine is not only effective in preventing severe Corona virus infections, but that it's also a very safe vaccine. So this committee, these advisers to the FDA voted unanimously to recommend that the FDA gives emergency use authorization to the vaccine. Well, the acting commissioner of the FDA, Dr Janet Woodcock, has issued a statement saying that she plans to do that very quickly. Assuming this all happens as it's supposed to what's the timetable here for getting doses made and then distributing them without this is going to be fast doses are already made. As you previously reported there, there's four million doses ready to go. What happens now is what will get an authorization from the FDA. And they say they'll do that so we can expect that probably tomorrow. So Andy slave it who's chief advisor to the White House on these matters, says he expects the FDA to do that tomorrow Saturday. Then it's up to the CDC to decide what people should actually get This authorized vaccine. So the CDC s advisers see Advisory Committee on Immunization Practices will be meeting on Sunday, and they'll vote whether Americans should get the vaccine. They may also have some advice about who should get this particular vaccine. CDC director will then say OK, go and the U. S. Is ready to roll with ease, The White House says immediately, which means probably Monday. Maggie quickly before we go. Can we get enough vaccine quickly enough to blunt the rising variants? That is the race? That's what everybody's worried about These variants. Some of them appear to be more contagious and really the best way to get out in front of that is to get as many people vaccinated as fast as possible. Johnson. Vaccines boost that a little bit, but they don't have a whole lot of vaccines ready to go until the end of

FDA President Biden Maggie Fox Sean Anderson Hilary Howard CDC Johnson Dr Janet Woodcock CNN White House Advisory Committee On Immuniza Andy Maggie
"janet woodcock" Discussed on KCRW

KCRW

05:48 min | 8 months ago

"janet woodcock" Discussed on KCRW

"I'm Ari Shapiro and I'm Mary Louise Kelly. The Corona virus is mutating. We know that worrisome new strains are popping up around the world. We know these variants could reduce the effectiveness of vaccines in preventing covert 19 so manufacturers may need to update those vaccines. But how well companies prove to the Food and Drug Administration that these changes are safe and effective. NPR pharmaceuticals correspondent Sidney Lumpkin says the agents He is working on a plan. He said me. Hey, Mary Louise first just catch us up on how widespread these variants are in the U. S. So there are now nearly 1000 confirmed cases of variant strains of covert 19, and that's considered an understatement. Most of the variant strains are those first identified in the United Kingdom. But there are others scene originally in Brazil and South Africa that are causing some concern. Some of the mutations allow the virus to more easily infect people, and some make it harder for immune systems to fight the virus off. So the fear is that the vaccines that the United States has spent billions of dollars researching, developing and purchasing will be rendered less effective. And how will we know? Will it be immediately obvious if the vaccines are just not working well enough against the variance? Well, it's definitely not time to panic yet Dr Anthony Fauci and said during a White House briefing this week that the Madonna advisor vaccine seemed to be effective against the variant identified in the UK That's the very an expected to become the dominant strain in the U. S by the end of March. So he says, to keep following public health guidelines and getting vaccinated as far as when it's time to change the vaccines. Here's Dr Paul off it, who serves as an adviser to the FDA, You know that the line is crossed if you see people who are fully immunized with these vaccines that say the immigrant vaccines But nonetheless when infected with a variant or being hospitalized, That's when the line gets crossed and that the date that has not happened Still everyone should prepare, he says, and the FDA is doing that. And how is the FDA? Preparing? How would they go about evaluating an altered vaccine? Or I suppose maybe we're talking and altered booster shot. Lot is up in the air. But FDA officials have said they're working on a playbook and they'll publish guidance documents for industry in the coming weeks. What we do know is that the agency is aiming to be nimble, which likely means officials will look for studies of a few 100 people, rather than the tens of thousands required the first time around. Acting FDA Commissioner Dr Janet Woodcock says. A lot will depend on how fast variance trains crop up. And how the existing vaccines stand up to them. So the situation is very fluid, but we think they're things short of doing full pledge 60 trials that we can use. To shift or perhaps add components to existing vaccine. She says the agency will likely also convenience advisory committee before making a decision on an updated vaccine on how long how long might that take? Probably a few months. Of course, this pandemic is unprecedented in so many ways, but we can look to historical examples for clues. Genevieve Cantor, a health economist at the University of Pennsylvania, says the best analogy is the H one and one pandemic in 2000 and nine That year, the FDA learned about the seriousness of H one n one after it had already approved the seasonal flu vaccine. It convened an advisory committee in late July. By September, mid September, 4 supplements had been approved. Against each one in one so they could do it you certainly under two months, it's worth noting that it takes the agency time to carefully review reams of data and documents. The public usually first hears about trial results from company press releases. But the FDA needs to make sure that the underlying data are solid that the company can make the vaccine according to its own recipe, and that the shots stay stable when they're stored and transported. So many moving parts. That's NPR's Sidney Lumpkin. Thank you. You bet. When the federal government started making pandemic loans to help keep workers on payrolls. Businesses owned by black and Latino people were often at the back of the line. Those firms often had to wait longer for money, even though many were desperate for financial help. With a new round of business loans in the pipeline. Authorities are now trying to address that disparity as NPR's Scott Horsley reports. Like a lot of business sellers. Jennifer Kelly's income took a hit last year when the pandemic struck. She's a clinical psychologist near Atlanta, and some of her clients didn't make the adjustment to online or telephone counseling. Kelly, who has two employees applied to her regular bank for a loan under the federal government's Paycheck protection program. But she says the process was frustrating. It's kind of like trying to get the vaccine. They put my name on the list. And there they, Polly said, Oh, we all have anymore, And we're sorry that first round of P P p loans was exhausted In less than two weeks. Lots of businesses complained that banks were prioritizing their biggest customers. Loans were especially hard to come by in neighborhoods with a lot of black and brown residents When I needed them, they were not available to you and including I'm not the big business, but I'm a small business and communities like with the fabric of America. When Congress okayed a second round of P P p loans last year, Kelly applied again. This time through a bank 250 miles away in Savannah, Georgia that specializes in working with black own firms. They were very patient through that entire process, and I didn't get approved for the loan, and I do hope. That especially the small black banks will survive because we need to have those institutions. But second bank Kelly worked with Carver State Bank was founded 94 years ago with the goal of.

Food and Drug Administration Mary Louise Kelly Sidney Lumpkin federal government NPR pharmaceuticals Ari Shapiro flu vaccine Dr Anthony Fauci Mary Louise United Kingdom Dr Paul United States NPR America Polly University of Pennsylvania Dr Janet Woodcock Carver State Bank
"janet woodcock" Discussed on 860AM The Answer

860AM The Answer

02:24 min | 11 months ago

"janet woodcock" Discussed on 860AM The Answer

"Although President Trump refuses to concede the election, he has agreed to allow Joe Biden to begin the transition process. President maintains that he has a strong legal case and believes he will still prevail. But he's also directing his administration to cooperate with the incoming Biden team as the transition begins now that the General Services Administration has determined Biden won the election. The former vice president will have access to transition funding and open communication with government agencies to ensure a smooth transfer of power. Greg Clugston Washington The former adviser to President Trump, Salem tacos, Dr Sebastian Gorka suggested Mr Trump's ongoing battle to make sure that all of the legal votes have been counted. Should come as no surprise his career and his presidency. Trump has set goals and done everything he could within the law to achieve them. He accepts defeat but never gives up. However, Gorka notes of both time and options are running short to effectively challenge the election's outcome. Number of states and cities tightening coronavirus restrictions Hoping to solve the spread of the virus. The federal government today starts distributing 30,000 doses of an experimental antibody drug to fight Cove in 19. It's the same drug administered to President Trump. Just last month, given us a one time I V treatment to Corona virus patients who are at high risk of developing serious illness. Dr. Janet Woodcock and FDA advisor Toe Operation Warp Speed says study suggests the drug can reduce the pressure on hospital systems. That's correspondent Jennifer King. A rally is underway on Wall Street this hour. The Dow is up 345 points less than 100 points away from 30,000, the S and P better by 30 and the National composite Index up 36 points more on these stories at town hall dot com. Say you've decided to build a bicycle from scratch. Sounds like an impossible project for my skills. But let's say you've got the skills and I offer you an advantage. A special tool that would help you build a bike faster while saving your legitimate money. My guess is you'd say, Bring it on. If you wouldn't Well, then this commercial isn't going to make much sense. My name is Ryan. I'm from the United Faith Mortgage and we believe we haven't advantageous tool for you. Our mortgage team is lucky to have a direct lender advantage our companies set up to use its own.

President Trump Joe Biden Dr Sebastian Gorka President vice president General Services Administratio Greg Clugston Washington federal government United Faith Mortgage Salem 30,000 Dr. Janet Woodcock Jennifer King Ryan Cove advisor FDA town hall
US to start distributing experimental virus drug

AP News Radio

00:53 sec | 11 months ago

US to start distributing experimental virus drug

"It's just been approved for emergency usage by the FDA now the government shipping an experimental drug the second anybody treatment for coronavirus patience health and Human Services secretary Alex a stark says the government will start distributing doses of an experimental anybody drug to fight Kobe nineteen it's the same one president trump received last month we expect to distribute about thirty thousand doses of the Regeneron product tomorrow with more to come in the ensuing weeks it's given as a one time IV treatment a coronavirus patients who are at high risk of developing serious illness Dr Janet woodcock and FDA adviser to operation warp speed says studies suggest the drug can reduce the pressure on hospital systems CBOE high risk patient had a nine percent chance of hospitalization or even death that persists three percent of treated individuals earlier this month the FDA allowed similar use of drug from Eli Lilly Jennifer king Washington

Coronavirus Patience Health An Regeneron FDA Dr Janet Woodcock Stark Kobe Alex Cboe Eli Lilly Jennifer King Washington
"janet woodcock" Discussed on The Last American Vagabond

The Last American Vagabond

04:04 min | 1 year ago

"janet woodcock" Discussed on The Last American Vagabond

"On the FDA part of this before we get into Google oracle aspect of it because it's it's it's people tend to think. Naive. That the FDA in the CDC, these groups are there to protect Americans. When in reality, there are just wildly politicized cooperative groups by the government in my opinion today. So what are the parts that stand out about the FDA you had mentioned that there is some obvious conflicts of interest and overlap with the program and people involved with doing all this stuff. So could you don't on that for me? Right well, here it says right pharmacovigilance it'll be done between operation ward speed in conjunction with the FDA in the CDC as I note here. The FDA despite claims that they're going to be involved in this pharmacovigilance system top FDA officials said in September they were being barred from attending warp speed meetings, but it's not just attending can't even sit in so like they can't even observe the meetings, which is just so odd. Also. Top FDA officials told mainstream media reporters not. Real reporters right. They could not explain operation how Operation Works was organized and winner with what frequency operation were speed leaders meet on but they said we're still allowed to interact with the companies developing warp speed products they're still allowed to do that. All right FDA. But then they go on that the same article Stat News that I linked to in here on says that the FDA has set up a firewall between most of their staff in operation warp speed. meaning that, basically, all the INFO about work speed is stove piped through this firewall meaning. There's only one or two tops, people, points of contact that link the FDA to operation warp speed, and as I point out here, this is Janet. Woodcock lady is the only FDA official involved in operation work speed. She took temporary leave from her role as the director for the of the Center for drug evaluation and research at the FDA. In order to focus entirely operation warp speed I believe since June and she has a lady that is has stepped in for her who's a former Pfizer executive, and of course, Pfizer is one of the operation warp speed vaccines and to go, and so the lady that's replacing Janet Woodcock at the FDA is this lady Patrizia Compass Zony on if we go, here's an article, all about cavs Zony from June..

FDA Operation Works Patrizia Compass Zony Janet Woodcock CDC Pfizer Google official director executive
"janet woodcock" Discussed on KOMO

KOMO

02:07 min | 1 year ago

"janet woodcock" Discussed on KOMO

"An award winning rock star and songwriter is died from complications due to coronavirus Schlesinger was the bassist and songwriter for fountains of waste the pop rock group scored their biggest hit with two thousand three Stacy's mom a couple years after Schlesinger's Oscar nomination wrote the title track for the next ninety six Tom Hanks directed film that thing you do Schlesinger also scored an Emmy writing songs for the TV series crazy ex girlfriend and he had a Grammy for writing and producing the album a colder Christmas Adam Schlesinger was fifty two J. Symington's at ABC news Hollywood the FDA is asking manufacturers to pull a common type of heartburn medication needed the medications commonly sold under the brand name zantac have been found to pose a risk if stored improperly according to the FDA which is now asking manufacturers and stores to pull them Dr Janet woodcock with the FDA says they discovered a probable carcinogen can form certainly learned about the presence of these impurities and we immediately undertook a major operation to investigate and identify the root causes she says to dispose of these medications if you have them in your home Markram Alard ABC news federal prosecutors say West Virginia governor Jim justice's coal companies have agreed to pay more than five million dollars for thousands of mine safety violations a civil case sought claim payments on nearly twenty three hundred violations committed since twenty fourteen this is ABC news coverage time eight oh four every ten minutes on the foresters Tama Fulton still watching it reports of a structure fire in average it's caused by a propane tank explosion and that's causing of the fire department have to make a big clean up this is near the average in the every area of the marine equipment fire station incarnation still watching highway two agrees but reduced to just one link between north east still water hill road in northeast eighty eighth street traffic is being alternated through in that one line and that's causing backups of just about every eighth of a mile in each direction approaching the area our next come on traffic at eight fourteen Shero doll with your.

Jim justice Shero West Virginia heartburn J. Symington Emmy Oscar fire department Tama Fulton ABC coronavirus Schlesinger Dr Janet woodcock FDA Hollywood Adam Schlesinger Grammy Tom Hanks Stacy