40 Burst results for "fda"

Fresh update on "fda" discussed on Night News

Night News

01:21 min | 38 min ago

Fresh update on "fda" discussed on Night News

"All right, Thank you, Mike Little, the CBS News time 11 10. Researchers at the California Institute of Technology say this new strain that first started popping up around the New York area in late November of Cove. It Since spread to neighboring states, But help could be on the way tonight. The FDA approved visors request distorts vaccine in pharmacy freezers for two weeks instead of ultra cold specialized units. This is Visor and Moderna are testing whether of booster shot of their vaccines can protect against the variant identified in South Africa. But we care about is making sure people don't get sick. They don't get hospitalized and, of course, most importantly that they don't die. Meg Oliver CBS NEWS NEW YORK After weeks of not having enough New York City officials say they now have a surplus of covert 19 vaccines, since shipments delayed by last week's winner storm have now arrived. So this city's vaccination sites are now staying open longer and taken more appointments sites at the Brooklyn Army Terminal, Bathgate Industrial Park in the Bronx and Citi Field in Queens. They're adding overnight shifts. And Mayor Bill de Blasio says the city is doubling the number of appointments at sites in communities where they're focused on fighting disparity. In other words, getting more blacks and Latinos vaccinated. It's 11 11. We'll get two sports in a minute. Nice night for the local teams. New Dove men, deodorant is different..

Meg Oliver Mike Little South Africa New York FDA Bathgate Industrial Park Last Week Two Weeks Mayor New York City Late November Citi Field Tonight California Institute Of Techno 19 Vaccines Brooklyn Army Terminal Two Sports Moderna Cbs News
FDA Expands Recall For Cheeses From New Jersey-Based Company Amid Multi-State Listeria Outbreak

10 10 WINS 24 Hour News

00:30 sec | 3 hrs ago

FDA Expands Recall For Cheeses From New Jersey-Based Company Amid Multi-State Listeria Outbreak

"Alito cheese company They're saying the cheeses source of the multi state listeria outbreak we've been hearing about. They issued the first recall our last Friday for case alfresco. Now they've expanded into all fresh cheese products from that company with expirations dates through March, 28th. Product sold to multiple states, including New York, New Jersey as well as Connecticut, telling you to throw it away. If you bought some of it recently or just take it back to the store, you got from to get a full refund. But light and Coors Light Breweries have been doing all they can to take the calories out of your

Alito Listeria New Jersey Connecticut New York Coors Light Breweries
Fresh update on "fda" discussed on WTOP 24 Hour News

WTOP 24 Hour News

00:28 sec | 43 min ago

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

"Said. We should start seeing those doses arrive in our state next week, which is tremendously exciting is going to add to the arsenal to go after this virus state is also preparing to set up a single platform to sign up for vaccination appointments. But on Lee for the mass vaccination sites, Kate Brian w. T. O p new now one of the other covert vaccine manufacturers just gotta break that could streamline distribution. The FDA says Fizer no longer has to store their doses and ultra cold freezers. That normal freezers will serve ice. Up. Until now, The super cold fridges have hampered efforts to storm handout doses quickly coming up after traffic and weather and alleged rape case and a Montgomery County High school is now taken to federal court. 11 07 time.

Next Week FDA LEE Montgomery County High School ONE Kate Brian W. T. O P Fizer Single Platform 07 Time 11
AstraZeneca working to adapt vaccine to new strains

Night News

00:38 sec | 3 hrs ago

AstraZeneca working to adapt vaccine to new strains

"England, tell CBS News that they are racing to develop a new vaccine to fight these dangerous new strains. More of those vaccines. Already available from CBS is Meg Oliver. Tonight, the FDA approved visors request distorts vaccine in pharmacy freezers for two weeks instead of ultra cold specialized units. This is Speiser and Moderna are testing whether a booster shot of their vaccines can protect against the variant identified in South Africa. We care about is making sure people don't get sick. They don't get hospitalized and, of course, most importantly that they don't die. Meg Oliver, CBS NEWS New York and we've just learned the Senate

Meg Oliver Cbs News Speiser CBS Moderna England FDA South Africa New York Senate
Fresh update on "fda" discussed on News, Traffic and Weather

News, Traffic and Weather

00:34 min | 54 min ago

Fresh update on "fda" discussed on News, Traffic and Weather

"Johnson and Johnson's Cove in 19 vaccine. The FDA could make a decision by Friday evening. Those air political insights I'm faithful booby, ABC News The Equality Act, which would end discrimination based on gender identity or sexual orientation passed the House of Representatives, but it may not be as successful in the Senate Here's congressional correspondent Rachel Scott. This is going to face an uphill challenge in the Senate. Democrats need the support of at least 10. Republicans on Lee, three in the House vote with Democrats move forward with this Republicans are concerned about this room infringing on religious liberty and President Joe Biden did make it part of his 100 Day agenda. A telling us they may have to push that timetable back. Two new candidates who are running for the Seattle City Council are familiar names in some circles. The story from Cuomo's Gregor shoulder. Brianna Thomas is the chief of staff to City Council president Lorena Gonzalez and Mike McQuaid is a South Lake Union community leader. Both are running for seats that represent the entire city, the rather than a district. Thomas previously worked on several campaigns, including the one that created a $15 minimum wage in Si Tak and the campaign that created the publicly funded democracy vouchers. She's running for the seat that Gonzales is giving up to run. Mayor McQuaid owns a strategic communications business. He's served on the South Lake Union Community Council for much of the past decade, and he's challenging incumbent to racing Mosqueda. Greg Hirsch Holt Co. Moh news. Homo traffic.

Brianna Thomas Mike Mcquaid $15 House Of Representatives South Lake Union Community Cou Thomas Rachel Scott Greg Hirsch Friday Evening FDA Lorena Gonzalez Democrats Republicans 100 Day Mayor South Lake Union City Council Gonzales Seattle City Council Three
The Latest: US loosens Pfizer vaccine shipping regulations

AP News Radio

00:41 sec | 4 hrs ago

The Latest: US loosens Pfizer vaccine shipping regulations

"Hi Mike Rossi you're reporting government regulators ease the temperature requirements for the Fizer coronavirus vaccine new data from the manufacturers has prompted the food and drug administration to loosen shipping and storage requirements for the Fizer Cole did nineteen vaccine the FDA says going forward the Fizer vaccine can be shipped and stored for up to two weeks at temperatures of freezers commonly found in pharmacies until now ultracold temperatures from minus seventy six degrees to minus one hundred twelve degrees Fahrenheit or required for shipments and storage of the frozen Fizer vaccine vials the chain should ease distribution and administration of the Fizer vaccine might cross CO Washington

Mike Rossi Fizer Cole Food And Drug Administration Washington
Fresh update on "fda" discussed on Mark Levin

Mark Levin

01:09 min | 1 hr ago

Fresh update on "fda" discussed on Mark Levin

"Using the meals on Wheels program. Identify seniors who want the shot but can't make it to a pharmacy or a hospital. Frustration at FEMA's covert vaccine Super cited in Archie Park, this woman received a text to come get her second dose of the modern a vaccine. But after waiting in line, she was turned away because they only have the Fizer vaccine available today. I started cry. Was distraught. I was hurt. I was disappointed. Itwas all for not saying that from our TV partner, Channel Two. Similar issues were reported yesterday as well. And speaking of the Fizer vaccine. Fizer. Vaccines no longer have to be kept at ultra cold temperatures during Transportacion today, the FDA said the vaccines can be stored for up to two weeks at conventional temperatures found in pharmaceutical freezers. And finally tonight, it's the lowest flu season on record. February's traditionally the worst month for flu cases, but social distancing face mass virtual learning for covert have resulted in the U. S. China in Europe across northern Hemisphere reporting very few cases. This time last year there had been 92 pediatric deaths. But so far this year, only one child has died of the flu. News on demand to ktrh dot com. Our next update at 9 30 breaking information as it happens, I'm Wyatt Goolsbee for news radio 7.

Last Year Fema Channel Two Yesterday Wyatt Goolsbee Tonight Second Dose FDA U. S. China This Year February One Child 92 Pediatric Deaths Northern Hemisphere Today Europe 7 Up To Two Weeks Ktrh Dot Com 9
New coronavirus variant in New York spurs caution, concern

KYW 24 Hour News

01:05 min | 5 hrs ago

New coronavirus variant in New York spurs caution, concern

"Discovered a new variant of the virus in New York City, and that it is spreading quickly. Even more frightening. Current vaccines may not be as effective it fighting it. The nation's top infectious disease, doctor, Anthony Fauci said today. The best way to stop those new variants from spreading is to get Americans vaccinated as fast as possible. And as we come on the air tonight, the FDA is taking a big step to making that happen. The agency now says Fizer is vaccine no longer has to be shipped or stored at those sub zero temperatures. That's a huge breakthrough that will make it easier to get shots two sites across the U. S. And we're also learning that visor and Moderna are now working on possible booster shots of their vaccines. That could mean getting a third dose to help fight off these new variants At the White House tonight, President Biden is celebrating, saying 50 million shots have now been given out nationwide since he took office half of the 100 million he promised to deliver in his 1st 100 days. Combined with the shots given out during the Trump administration, That means nearly 68 million doses have been administered across the country. We've got a lot of new

Fizer Anthony Fauci Infectious Disease New York City President Biden Moderna FDA White House Trump Administration
Fresh update on "fda" discussed on Tim Conway Jr.

Tim Conway Jr.

00:37 sec | 2 hrs ago

Fresh update on "fda" discussed on Tim Conway Jr.

"Those kids 7 11 loser Dad like that so quickly. I just terrible. All right, we're live on K if I am 6 40 more news now. Debra Mark Theo FDA says it will now allow fighters covert 19 vaccine to be transported in stored for up to two weeks that pharmacy freezer temperatures. The change is expected to make it easier to distribute the vaccine. U. S forces have completed an air strike against a facility belonging to Iran supported militia in Syria. President Biden apparently approved the air strike because of recent attacks on U. S forces in Iraq. The House has passed a bill that would provide more protections for the LGBT community. The Equality Act changes an existing civil rights law to include sexual orientation and gender identification as protected characteristics. Change would apply to employment, housing, education and more. We're going to go to the four or five next. Well, for many of us home has become.

Syria FDA Equality Act Iraq Five 7 11 Debra Mark Theo 40 U. S Forces 6 Four House 19 Vaccine President Biden Up To Two Weeks Iran
Johnson & Johnson Covid-19 vaccine is safe and effective, FDA analysis finds

Glenn Beck

00:34 sec | 14 hrs ago

Johnson & Johnson Covid-19 vaccine is safe and effective, FDA analysis finds

"Vaccine. Assumes against final approval from the FDA. Dr. Anthony Fauci says people shouldn't wait for more effective vaccine if the Johnson and Johnson shot is available when the vaccine becomes available. Take it. I mean a vaccine when the vaccine gets by the FDA in an emergency use organization and then ultimately, hopefully in a in an actual full approval. Take the vaccine. White House covered coordinator Jeff Science expects 3 to 4 Million new doses to be available. Pennsylvania man charged in a capital riot learned the hard way the

Dr. Anthony Fauci FDA Johnson Jeff Science White House Pennsylvania
Fauci urges Americans to take whatever vaccine is available

AP News Radio

00:52 sec | 14 hrs ago

Fauci urges Americans to take whatever vaccine is available

"A third vaccine is likely to soon join the covert nineteen fight but the nation's top infectious disease expert is urging Americans not to be picky Dr Anthony Fauci knows people look at vaccine studies and compare effectiveness seventy two percent versus ninety five percent and so on they may then decide well just wait for the next more effective one that I think is not a good idea algae on NBC news today show saying people should be confident in any vaccine the FDA approves for emergency use when the vaccine becomes available take it Johnson and Johnson's vaccine will take its turn before the FDA's independent advisers tomorrow and felt she's looking forward to with joining the dharna and Pfizer vaccines already in use they have to it's fine to have three is absolutely better soccer mag ani Washington

Dr Anthony Fauci Infectious Disease Nbc News FDA Johnson Pfizer Soccer Ani Washington
Johnson & Johnson's single-dose vaccine is effective and ready to ship

Steve Scott

00:50 sec | 18 hrs ago

Johnson & Johnson's single-dose vaccine is effective and ready to ship

"Scott 5 31 at WCBS. Johnson and Johnson says it is ready to ship four million doses of its covert vaccine just too soon as it is granted emergency use authorization from the FDA, and that could happen as soon as tomorrow. Scientists say the one does shot is safe and effective and appears to work against all variants. Your CBS News correspondent Natalie Brand, the FDA review of the J and J vaccine, found it to be safe and 85% effective at preventing severe illness. 66% protective overall, taking some new variants into account. It does show very, very good protection against serious illness, hospitalization and death, and Madonna says it has sent candidate dose is specific to the variant first detected in South Africa to the National Institutes of

Wcbs Johnson Natalie Brand FDA Scott Cbs News Madonna South Africa National Institutes Of
Johnson & Johnson Covid-19 vaccine is safe and effective, FDA analysis finds

First Morning News

00:36 sec | 18 hrs ago

Johnson & Johnson Covid-19 vaccine is safe and effective, FDA analysis finds

"Johnson and Johnson's single dose vaccine could win emergency approval from the FDA tomorrow. The FDA has already said it's safe and effective Independent review board for the FDA will scrutinize the data around Johnson and Johnson single shot covert 19 vaccine before making a recommendation to the FDA. If all goes well in the FDA approves the vaccine. White House covert response coordinator Jeff Science says it will add millions of doses to the U. S supplies. Johnson is announced. It ain't to deliver a total of 20 million doses by the end of March. He says 3 to 4 Million doses of the vaccine could potentially be added to next week's

FDA Johnson Jeff Science White House U.
Johnson & Johnson COVID-19 vaccine deemed "safe and effective" by the FDA

Daily Coronavirus Update

07:10 min | 18 hrs ago

Johnson & Johnson COVID-19 vaccine deemed "safe and effective" by the FDA

"And johnson. It's been shown that they're vaccine is effective at preventing hospitalizations and severe effects of covid. Nineteen this from scientists at the fda we're seeing about. I think it's sixty six percent effective when it comes to moderate to severe cases of covid nineteen so matthew. Tell a little bit more about what we're hearing with. His johnson and johnson vaccine right so what happened. Is that johnson. Johnson released data about a month ago. You know press release but the process for evaluating these vaccines is that they go through the fda and the fda really unique in the world independently looks at the data and re analyzes the data that the company produces and its own report and then hold a public meeting which will be happening friday and so the documents before the public meeting came out and they had some good news both some really clear data on hospitalizations and a general sense of approval from the fda researchers. Sometimes they're not as positive so it looks like this may be another option now. The big plus is on. This is one. It's a one shot dose. So you don't have to go back for a second jab in the arm and also doesn't need to be kept frozen like the pfizer derna vaccines do so shipping and handling of all of this will be a lot easier much easier to transport and that's a big advantage. It does not look like we're gonna have a huge amount of supply the start off with so it doesn't dramatically change how fast we're going to be any shots into people's arms but for a lot of people i think in a lot of experts i talked. You think this'll be a great option. It's one and done. I think some of the numbers. I saw the might have about four. That are produced right now. Ready to send out so it gets approved. They can get those out really quick but it wouldn't be until april possibly where they can really ramp up production to start distributing that right and will also be getting over that where they're hundreds of millions of doses of the two vaccines have the madonna and fayza biontech vaccines. That are expected to arrive in the us by july. So there's gonna be a lot more vaccine available. The jj supply will ramp up and we'll be getting more of those other two vaccines that leaves. There's a vaccine coming from nova vacs. We don't really know about how much will getting the early results issued press. Release again good and we're waiting for. Us results on the astra zeneca vaccine. Now some good news. With his johnson and johnson one is its effectiveness against these variants. That we've been hearing a lot about so it fared better than expected when it comes to those. I the way to interpret. That is we'd seen some results and the new results that they showed today look a bit better than what we'd seen in terms of variants. There's still does seem to be decreased. Efficacy against the south africa variant. Three five. Which is really the one that we're all worried about but it did look better than what we've seen previously and what j. j. has said it seems like with those variants. This vaccine is still preventing severe disease and hospitalization. Which are the key things. We've always wanted from vaccine here. The idea that you'd prevent a symptomatic infection or mild cases kind of bonus compared to just making sure that people end up in the hospital hospitalizations numbers were good on that front. What did we see when it comes to side effects. I saw that there were a few unexpected side effects. Although these are very rare you know but The expecting side effects the kind of pain in the arm the headache fatigue. That's pretty much in line with the other two vaccines. We have that right now. There were some rare events that occurred more often in the vaccine in the placebo group. Keeping in mind that forty thousand people were in this trial. There were fifteen serious blood clots including some. Dvd's in that exciting compared to ten in the placebo group. That's something the fda plans to monitor there was also some rini ears in the vaccine group and not in the placebo group. So that's kind of an odd one that will wanna watch again. This is really a prelude to friday win. Some of the top experts in the world are going to gather on zoom call and go over these data that the fda assembled we'll be live blogging that stat. That's when we really find out a lot about any medical product. It's it's one of the amazing things. The fda does now an interesting thing in all of this so public health officials might have a messaging problem when it comes to pumping the johnson and johnson. One out when we're seeing guys like pfizer maderna's say that their vaccine is ninety five percent effective against corona virus. Just listening to numbers right. This says sixty six percent. So what are they going to have a challenge in getting people to want to take this one over the other or you know how how to work out. It's really important to realize that particularly between those three vaccines. The getting vaccine is much better than not getting a vaccine. The change vaccine may be on par after a second dose and that study is being done but unlike visor during the second dose is going to be months after the first and then also slows down the study. She gotta wait right for people to get their second dose. So we're not expecting those data until kinda summerish but the big thing is for a lot of people. There was also the appeal of a single dose here. And i don't think we should understate that. And the effect on severe disease is big so the problem is gonna be the in the initial rollout. You really want people to take whatever vaccine. They're giving because being vaccinated is so much better than not being vaccinated. And that is part of the path to get in the world back to normal and public health. Authorities are absolutely going to have to articulate that now again because there's not going to be that much supply of this initially. They're going to have time for a learning curve right now. the demand for vaccines clearly outstrips supply. That's why you're hearing so many stories of people desperately logging on trying to get vaccine. What scott gottlieb used to run. The fda has raised the issue of you know. We're we're going to reach a point where the people who wanna get vaccinated we'll have been vaccinated and we're still going to need to vaccinate more people and that's when convincing people who are less sure to take vaccine in to take the vaccine that's available is going to become more of an issue last question briefly pfizer moderna vaccines are based on 'em a. What kind of platform is the johnson and johnson. When using this like theatrics annika vaccine is called an ad no virus which is a kind of virus that is used to the same kind of ideas marin a the instead of traditional vaccines were you inject the protein that your immune system sees and then learn to recognize an attack. These sneak something into your body that makes a lot of proteins. You make a lot more protein and then the body recognizes that an attack it in this case they're using this virus which is kind of a cold virus to sneak some genetic material in and that makes the spike protein from the sars virus which your body then learns to recognize and thereby has antibodies that attack the virus

Johnson FDA Astra Zeneca Pfizer Pfizer Maderna Matthew Nova Rini United States South Africa Headache Scott Gottlieb Marin Cold Virus
Pfizer COVID vaccine found 94% effective in real-world study

Coronavirus 411

00:42 sec | 18 hrs ago

Pfizer COVID vaccine found 94% effective in real-world study

"A real world testifies vaccine and more than half a million people in israel confirms that even after one dose it's very effective at preventing serious illness or death ninety two percent effective at preventing severe disease after two shots and sixty two percent after one and it was equally effective in young people. And those over seventy. The fda is one step closer to authorizing johnson and johnson's one dose vaccine for emergency use panel meets tomorrow to make a recommendation so far. The fda's review noted the vaccine to be sixty six percent effective overall in preventing moderate to severe covid nineteen and it has a favorable safety profile.

Israel Johnson FDA
Johnson & Johnson COVID-19 vaccine deemed "safe and effective" by the FDA

AP 24 Hour News

00:25 sec | 1 d ago

Johnson & Johnson COVID-19 vaccine deemed "safe and effective" by the FDA

"Say the Johnson and Johnson single does. Corona virus vaccine is effective against cope in 19 Dr Paul off it. You wanted to keep you out of the hospital out of the intensive care unit and keep you from dying and and certainly all the vaccines virus vaccine during the vaccine into Johnson and Johnson vaccine appeared to do exactly that on FDA panel will discuss then vote on the vaccine Friday. An emergency approval could be made in just a few days after that meeting, a real

Johnson Dr Paul FDA
J&J's COVID-19 Vaccine Is Safe and Effective, FDA Says

Buck Sexton

00:29 sec | 1 d ago

J&J's COVID-19 Vaccine Is Safe and Effective, FDA Says

"Is safe and effective against coronavirus, and they're endorsing it for emergency use. The vaccine is said to be about 66%, effective in preventing moderate to severe cases of covert 19 governor to Santa says it's been shown to prevent all hospitalizations and deaths. And he says, that's a win. No one wants to get infected with anything. But if you get infected and it's mild and you move on, that's a win. Given that this is something that can obviously be more threatening to people, a new mass covert vaccination site open this morning in

Santa
Single dose of Johnson & Johnson vaccine is 66% effective, say U.S. regulators

KOGO's Evening News

00:37 sec | 1 d ago

Single dose of Johnson & Johnson vaccine is 66% effective, say U.S. regulators

"Vaccine, the one from Johnson and Johnson. Could be out for US approval as soon as Friday. The Food and Drug Administration's report says Johnson and Johnson's vaccine is about 66%, effective at preventing moderate to severe covert 19 on advisory committee meets Friday to debate whether it's strong enough to recommend it and the FDA is expected to make a final decision after that. If it's cleared, it won't mean a huge boost to vaccine supplies right away. Only a few million doses are expected to be ready for shipping in the first week. The Johnson and Johnson vaccine requires just one dose and can be stored at normal refrigeration temperatures for three months. Let's try and J

Johnson Food And Drug Administration United States
Biden orders review of critical supply chains amid chip shortage

Michael Savage

00:21 sec | 1 d ago

Biden orders review of critical supply chains amid chip shortage

"Of critical goods in America's supply chain. The president says What is learned will not only boost productivity at home, but build stronger partners abroad. Nations share our values so that our supply chains can't be used against us as leverage. Biden says. Shortages like we saw PPE early in the pandemic can never happen again. Fox is going all Scott. The FDA says Johnson

America Biden FOX Scott FDA Johnson
F.D.A. Analyses Find Johnson & Johnson Vaccine Works Well

All Things Considered

03:31 min | 1 d ago

F.D.A. Analyses Find Johnson & Johnson Vaccine Works Well

"May soon be available in the United States. The Food and Drug Administration could decide as soon as this weekend to authorize a vaccine made by pharmaceutical giant Johnson and Johnson for emergency use. The FDA today released its evaluation of the new vaccine and NPR's Joe Palka joins us to describe what they found Hijo. Hi, Ari. So there were a lot of details in the FDA is evaluation, but bottom line. Was it positive or negative about it? Well, they don't exactly give conclusions like that. But general, you'd have to say that the analysis was positive. The FDA based its judgment on a large study involving some 40,000 participants that was carried out primarily in the United States, South Africa and Brazil. Now, this vaccine only requires a single shot, so participants either got the vaccine or a placebo. And what researchers found was that overall, the vaccine efficacy was about 66% in preventing moderate to severe cove in 19. And 85% against more serious disease. Stacy Schultz Terry is a professor of infectious diseases at ST Jude Children's Research Hospital, and she took a look at the FDA analysis. I did not see anything that would make me pause in recommending that somebody would go get this shot. Joe tell us more about that 66% number because a lot of people have zeroed in on that to say, Wait. Does this mean it's less effective than the Fizer and Madonna vaccines, which reported close to 95% of efficacy? Yeah, The numbers suggest that but you have to have a little context here. First of all, you have to remember that. Initially people would have been satisfied with the vaccine that was just 50% of efficacy. So this is the first vaccine to come. If this had been the first vaccine to come along, people would have been thrilled. Second vaccines behave differently when the rolled out to millions of people, and so there may be changes in the numbers going forward and third variants have popped up around the world. And Schultz Kerry says the Johnson and Johnson vaccine is the first to be tested against those and it did well, African see against the virus circulating in the U. S Good African see against thesis South African and the Brazilian variance as well. And the Johnson and Johnson vaccine is easier to store and distribute than the other two. Tell us about that. Well, yes, I mean, the first obvious thing is that the only requires one shot And that means people don't have to come back. You don't have to chase after them to make sure they get a second shot, so that makes logistic easier. And second of all, it's not as it's easier to store. It doesn't require these special freezers that the modern a vaccine requires. And so what happens next? We said there could be emergency authorization as soon as this weekend. Well, the process works like this. The FDA receives a bunch of material from the company and then they evaluated and that's what they released today and then before they make a decision, they convened a group called the Vaccine Advisory Committee. And they will meet on Friday to discuss and evaluate and two over the data, and by the end of the day, they'll issue some sort of a recommendation to the FDA and the FDA generally follows the recommendations of this advisory committee. And how much of a difference is this likely to make in the supply situation if there are three circulating rather than to now? Well, it's going to make a difference. Maybe not right away. There's going to be a few million three or four million doses released almost immediately if the vaccine is approved or authorized. 20 million. They expect by the end of March and 100 million by the end of June, so it's not going to solve the problem right away. But it will certainly help NPR's Joe

FDA Johnson Joe Palka Hijo Stacy Schultz Terry St Jude Children's Research Ho Fizer United States Schultz Kerry ARI NPR Brazil South Africa Madonna JOE Vaccine Advisory Committee
Johnson & Johnson's single-dose vaccine is effective, FDA says

Bloomberg Daybreak: Asia

00:08 sec | 1 d ago

Johnson & Johnson's single-dose vaccine is effective, FDA says

"S FDA preliminarily is saying Johnson and Johnson vaccine will get formal approval for use in a couple of days. One dose easier to

Johnson FDA
FDA staff endorses J&J’s single-shot Covid vaccine for emergency use

Gaydos and Chad

00:13 sec | 1 d ago

FDA staff endorses J&J’s single-shot Covid vaccine for emergency use

"The Johnson and Johnson covert vaccine has been deemed safe and effective by the FDA. It does not have to be stored in cold temperatures will humble with the Arizona Public Health Association says it's perfect for pharmacies, doctor's offices and community health

Johnson Arizona Public Health Associat FDA
How The AADA Empowers The Dealer Network  With James Voortman

Talking Automotive

03:00 min | 2 weeks ago

How The AADA Empowers The Dealer Network With James Voortman

"James. Thanks very much for agreeing to join us on the show. Great to have you With a person of your knowledge and expertise so just to start us off. Can you tell us about about two giant ford pandas and a bit of your your story and what you do look at the. Thank you for this opportunity to talk to you to that. But about james boardman well as you could probably tell from my accent. I'm south african. Night of dr hulda jason other day or until about two thousand nine when i decided to move to And coming from a background of public policy. I decided that cambra would be the best location from korea expected. Not everyone's face choice but was mon. And when i go out sort of got into the business of working for industry associations lobbying for industry and my first job in the automotive sector was with the australian automobile association which represents the staten territory modern club so cicely moderates and sort of vets event mice the my initial knowledge and also able to then use that to bosnia for a federal minister said laws on numerous issues and opting for few years. I was lucky enough to be employed by the wpa and three and a half years later on. I'm still here and united loving really enjoying working for a really interesting industry and wanna be anywhere else. Key question for me is what is the double idea. Seem to what are they a organizations so double. Ada what's the fda and come from. That's a great question. You know the people here in canberra and my predecessors ever blackwill used to talk about the alphabet soup of zone automotive associations got the mt aa the aa. Ada the sei all of these organizations and they're all all sort of unique in iran. Why but the double. I is the industry association. Which exclusively represents franchise. New deals are members of board is exclusively made up of franchise new car dealers and we advocated on behalf of that industry primarily to the federal government on range of issues as identified by this apple in its powerful. It's a fairly new organization. It's a little over seven years old and it just previously you would see dealers will Ston territory based martyred tried as associations and most of them still all members of Actions about about seven years ago. Number of senior figures within the industry decided that the needed no-go session which exclusively represented the needs of dealers at national level. And that's all the. I was think it's fair to say it's come a long way in the

James Boardman Dr Hulda Jason Cambra Australian Automobile Associat Staten Territory Modern Club Blackwill Ford James Industry Association WPA Korea Bosnia Canberra FDA Iran Federal Government Apple
"fda" Discussed on In the Bubble with Andy Slavitt

In the Bubble with Andy Slavitt

04:55 min | 6 months ago

"fda" Discussed on In the Bubble with Andy Slavitt

"That the FDA did what it said it was going to do it followed a process even if it's a little bit form-over-substance, a bit of enhances trust the vaccine from. Forty. Percent to seventy percent or some numbers which has as much to do with the vaccine effectiveness and achieving her immunity as the effectiveness of the drug. You buy my argument that's just as important a factor for the to take into account. I think it's a valid point of view and I mean you're pushing me to say what I would do if I were. In the job and you know what I would do is to try to get the trials done as quickly as possible. And have us out of interim analysis roles were clear and established ahead of time, and they would not be driven by an election day there'd be driven by the percent completeness of the data. That's the way we normally do interim analysis. In clinical trials, I'm just saying that if someone makes that decision, it's really important for us not to let politics on the other side, the Anti President side deny the public vaccine could say why? So that's all I'm saying. Yeah. That's exactly right. Anything else we should've talked about anything trapped you into saying that you wish you hadn't said that we can. We should add. Anything that I. Know You did new I'm so used to being questioned, but you know you are. So you're more judicious than I've ever seen. Well. You're you're you're you're very political host Air India I don't think I was being political. I don't think he's being political I. Really don't I think people are confused and I really worry about long-term trust in vaccines. and. If I'm suggesting that I think President Trump is inclined to interfere in the FDA. You think that's a political statement that's not a political statement. You're being provocative in the way you ask the questions, but that's that's fine that's because I was wasn't getting you guys were all for you wasn't getting clarity for folks on what it meant and whether or not we were in a strange spot or not, and I still don't think we still don't think you guys gave clarity but you know I. Think you guys did the best you could given. Given that you know it's there's limitations on your ability to be effective with the commissioner and as a public voice doesn't allow you. To not be even handed and provide even ended answers and I totally get that and I and I, totally respect that. All right man. Hopefully, it'll be helpful to some people that want to get sort of a balanced sense of. Where this God thank you so much. Appreciate it buddy. By. All.

FDA President Trump President commissioner
"fda" Discussed on In the Bubble with Andy Slavitt

In the Bubble with Andy Slavitt

02:23 min | 6 months ago

"fda" Discussed on In the Bubble with Andy Slavitt

"It's clear out for the country the message that get Kinda muddled the beginning, which is that that basks do help they do reduce the spread and I think having one that is both comfortable reasonable etc, etc. so a product like that walk through the optimal way for a product that to go through the process. Well, first off I, really appreciate all you've done and try to encourage people to. Wear masks to keep that six foot distance avoid big groups if just about all of us did that we'd be in much better shape for the pandemic. That's that's a that's an opportunity that's still there and we all need to keep working on together and you don't actually have to get FDA approval to start wearing a mask or the FDA comes in as if the mask manufacturer wants to be clear that that you know their product has a differential benefit differential factum for healthcare workers you. Know there were there's the so called in ninety five mass that were in short supply earlier FDA took some steps to get additional kinds of massive prove with an ninety five quality. They rejected a lot of mass to that claim to be that good and and really weren't and they also approve some ways of reusing these these e ohi medical grade. You know a emergency covert setting mass and it's possible to get some claims maybe below that level along the lines that that you're describing. And I think it could make a difference that the most important thing is that people should wear masks and remember that not all mass or created equal. The really thin ones are not so good the ones with Vance or definitely not good for protecting people around you. And that the more progress we can make, and hopefully FDA can can help us get there with mass that do a good job of of stopping droplets and that are easy to wear the better. So this is another of the many many ways in which FDA regulatory oversight Don in a way that keeps up with the science and the needs the pandemic is critically important. Thanks mark. You gotTa Run Robin. I'll finish up and We'll talk about your catch up.

FDA Vance mark Don
"fda" Discussed on KYW Newsradio 1060

KYW Newsradio 1060

01:40 min | 8 months ago

"fda" Discussed on KYW Newsradio 1060

"Facing FDA during the Copa nineteen pandemic is how do we sure the timely review of medical product applications despite an incredible surge in volume and constraints on our ability to construct in cycles factions I am pleased to announce today that FDA has maintained the same pace of meeting its goals on applications for medical products for the last six months that has maintained in recent years we are on target to meet our user fee goals for the drugs this year by reviewing and taking timely action on at least ninety percent of brand generic and biosimilar drug applications even during the pandemic additionally this work has continued at a time when the number of applications received in some centres is substantially higher than the pre covert nineteen times I want to thank the more than seventeen thousand please of tea at the FDA for their incredible efforts one that reflects the remarkable dedication and commitment to the public health of all Americans finally I'd like to discuss with us top of mind for all Americans namely the worked FDA's doing to facilitate the development of safe vaccines and therapeutics FDA launched emergency review and development program called the corona virus treatment accelerated program or C. tap and we continue to work night and day to provide guidance and to review proposals from companies scientists and researchers who are developing therapies let me be clear the data in science will dictate when we'll have safe and effective treatments and vaccines for covert nineteen as doctor felt you just mentioned toward that end FDA's using every available authority and applying every appropriate regulatory flexibility to facilitate development and testing we have not lost sight of our solemn.

FDA
"fda" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

03:51 min | 2 years ago

"fda" Discussed on POLITICO's Pulse Check

"There have been studies on teen pregnancy prevention that have been canceled. There's an agency wide review on fetal tissue research. And I've talked to officials political appointees career staffers who've said there's a there's a war at times between being pro-life and being pro science. Do you share those concerns, and if not do you understand why staff would have them? Well, I think with respect to the FBI look at the FDA, and I'm not I'm not following all the headlines that you are on all these other issues. I think with. Respect to the FDA. We've been very consistent and adherence to good science based decision making. I think my interactions with people in his administration have demonstrated not only an appreciation for the importance of that principle, but in a preoccupation for the unique mission of FDA. And I think impart why I've, you know, believed that I've been able to advance a robust policy agenda cross a lot of different areas that I believe is public health minded, advancing, you know, initiatives and programs that are gonna have a public health impact. Like what we've done on tobacco. Like what we've been able to do with respect to some of the changes made terms of how we regulate opioid drugs is because there's people in key positions of this administration, including secretaries are whoever deep understanding of FDA deep respect for its mission a deep respect for the science based decision making at the agency. And the secretary has been exceedingly supportive of the agency an exceedingly supportive of my Bill. To make independent decisions, you know, working with the professionals at at the FDA, and is one of the things I think I talked about the last time we spoke and one of the lessons. I learned when I work with Mark McClellan Moi's that it's very important that the the decision making and the ideas come out of the career staff FDA is not an agency where you can engage in top down policymaking where I can sit in my office with a Kabbalah people writing guidances and policy documents and try to impose it on on the, you know, the workings of the agency my job is to set out, you know, broad goals parameters public health goals that we're I think we should be investing our time try to get those resource, but the ideas in terms of how we're going to achieve them half to come from the professional staff, and it's my my job to work to make sure they get implemented. There was a recent survey by the union of concerned scientists that under the Trump administration many government science. Tests have been unhappy at places like EPA that is not the case FDA if anything happiness has been up under under your leadership one concern that some scientists have brought up to me is what the president has said at times about vaccines. You've been an unflagging champion Commissioner of the value vaccines. President Trump at times as questioned the Rafic ac- before being elected after being elected floated the idea of of vaccine safety commission. Have you ever spoken with the president about vaccines? I have not what would you tell him while I continue to speak privately about the things. I speak publicly. I don't think that my advice, privately is private and private is any different than my advice in public. I, you know, support support the role of vaccines. I think it's one of the greatest public health achievements of of humankind. Our ability to develop vaccines for vexing infectious diseases. I think that the, you know, the high vaccination rates that we've been able to achieve historically against pediatric diseases in particular have been one of the profound chievements of of modern. Medicine and to see those those gains reversed by fears that I don't think grounded in science and am talking particularly about some of the criticism around the MR vaccine would receive vaccination rates declining. And we see local communities putting in place ordinances allow people.

FDA president President Trump FBI Trump Mark McClellan Moi secretary Commissioner EPA
"fda" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

01:30 min | 2 years ago

"fda" Discussed on POLITICO's Pulse Check

"Wanted to help promote this opportunity for adult currently addicted adult smokers, but we said then, and we said all along that it cannot come at the expense of addicting a whole generation of young people on nicotine threes cigarettes. And that's exactly what's happening. We warned the companies we told them that we wouldn't tolerate it. And we're not going to be tolerating. You mentioned the moves that your agency has made last year FDA decided to push the deadline for regulatory review of the e cigarette products to August twenty twenty two almost four years from now. So putting that in plano. English e cigarettes can hit the market without approval from FDA. Why did you make that decision? And or you re thinking that while it was e cigarettes that were on the market as of two thousand sixteen can continue to stay on the market until that date, if I hadn't changed that date, the applications would have been do about a month ago or two months ago, and there's the potential that these products would have had to come off the market a year from now. I still think we are trying to strike the right balance between trying to more rapidly migrate adult smokers off of combustible tobacco by regulating the nicotine levels in in combustible cigarettes to minimally a non indicative levels while still providing an opportunity for adults who want to get access to satisfy levels of nicotine to do through products that are less harmful. That means nicotine replacement therapy. The least harmful form of nicotine delivery, things like, you know, gums and patches that you might be able by a pharmacy without a prescription. And we've put out new policy to try to promote development of those products. But it also could mean things likely attrac- nicotine.

nicotine FDA plano four years two months
"fda" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

03:07 min | 2 years ago

"fda" Discussed on POLITICO's Pulse Check

"I told you before when you asked me this question about a year ago, which is I'm very happy and the job I'm in and I will say beyond that. I think I'm in the job that I'm best suited for. I mean, this is the place where I think I'm going to, you know, deliver the best work for the administration and for the public health. You referenced our conversation on this podcast about a year ago. I asked you at that time to give a headline for what you thought the agencies work was if you were picking the headlines as a as a newspaper editor you responded with more of an essay than a headline. But that's just a quibble if you were picking the headline for twenty eight teen with the you're almost over. What would that be for FDA? You know, the headlines ends up being issue specific, I think that we've done some pretty bold things and things that are going to have a pretty broad impact on public health in a couple of different areas. I think that work that we've done in in tobacco is notable, frankly. And I think it's going to have a meaningful impact in perpetuity. I think the things that we've done to try to shift the agency. Orientation to the opioid crisis and think differently about what roll is with respect to that crisis are going to have a lasting impact. I hope they will. And I think some of the work we've done to try to promote competition are also going to have lasting impact. I look at it from the from the standpoint, if you're asking me what I think of the most notable things that we've done I look at it from the standpoint where I feel that we have changed the agency's relationship to important issues and with the agencies now thinking differently about its mission with respect to those issues, and those are three areas with agencies now thinking differently with respect to those issues through the work that we you know, that we've done together that that I've done with the leadership of the centers. Is an essay. It's the headline and the first couple of paragraphs of historic. We'll give you credit for over achieving and delivering more than than the editor asked for. Let's let's go through those interns who tobacco and even beyond tobacco Easter 'grats. And what the FDA is is doing in that area. This is a real life problem in a way that say Medicare payment regulations might not be I get emails from readers who say I am. I am worried about my teenage son or daughter using jewels vaping and in school. I don't get that same level of urgency around like the discrete regulations that are happening. You've said that FDA has data showing that use of of ping devices among teenagers, isn't ethnic. What do you know? And when will we find out about it is going to be coming up very soon? We're going to announce action next week. The first stages of our action next week in terms of what we're going to do to try to address the epidemic of teen use of cigarettes. And I've already said the data shows a greater than seventy five percent increase in the use of cigarettes. Year-over-year from twenty seventeen to twenty eighteen among high school students and about a fifty percent increase in the use of cigarettes among middle school students in this comes from the national youth tobacco survey. This is early data from the national youth tobacco survey where we looked specifically at the east cigarette. Use based on concerning trends that we spotted you know, and and it's not just that uses gone up, but but regularly uses gone up..

FDA editor seventy five percent fifty percent
"fda" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

01:52 min | 3 years ago

"fda" Discussed on POLITICO's Pulse Check

"Also balance that public health approach with which consumer advocates would really like to see happen so interesting things to watch in general they have to really implement and roll out a lot of food safety regulation that's kind of a legacy of the food safety modernization act so how they do that with limited resources in terms of educating farmers educating manufacturers importers to really get everyone focused on prevention will be interesting so he has a lot of work to do in 2018 it's possible congress i know on the drug cited may eventually add more stuff to their played there's been some brewing momentum to do an over the counter drugs revamp in terms of how those drugs are approved by the fda meb doing user fees for that there's also been talk of fda sort of not fda congress i am doing a new sort of legislation that would affect how fda regulate lab developed tests devices that often times are not regulated by fda narch um different like labs or universities have a lot of freedom and developing so they could have more responsibilities them their plate m in 2018 yup also one more thing to look for uh that consumers can actually see in their daily lives as starting in may a restaurants are going to be required after like you know an eight year regulatory process uh to post calorie count son all of their menus a lot of them are already doing it but in may it seems that that will actually be the deadline that kicks in after numerous delays so uh that will be a visible sort of fda policy finally kicking into place um it so look for those calorie count sin don't complain to us when i heard every time i see a menu and there's something i wan looks delicious and then it's like a thousand calories.

public health food safety thousand calories eight year
"fda" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

02:01 min | 3 years ago

"fda" Discussed on POLITICO's Pulse Check

"Medical background so it'll be interesting to see how these different personalities come together to shape has fda he he made the point when i think the last question was who's the smartest person in the who's now working ministration he showered out peggy hamburg obama who bomb hair ahead of the fda so looking at his again ability to try build bridges across the aisle yet so on the on the food side i think we mentioned nutrition just what is fda looking to do on that front um it's just going to be very interesting to see how you know a trump fda approach is like using a food nutrition policy to tackle the obesity epidemic which is a basically what he said you know he would like to see the agency do more of a and then on this recall issue you you ask the commissioner about a recent i'm inspector general report which basically cited fda's long long delays in some of their recall proceedings for food food safety issues so one of the most agree just ones was there were seminole a nut butter as they knew were contaminated with salmonella anna took like a hundred and sixty five days to initiate a recall so there's these example sort of coming out of where the agency has fallen down in moving quickly to get unsafe food off the market and in reacting to this report the agency's kind of saying well you know we're going to look at more rolling out more information and really at giving companies more guidance going into 2018 so how they approach that will be really interesting because if they for example uh make companies or start one of the things they could do is mandate or or really unveil retailer information so if there is a food safety incident they might name you know target walmart safeway this is where it was sold in this locations they don't do that right now in the idea of doing that's kind of controversial even though usda already does it so if he were to move forward on something like that it would be really interesting to see how they would approach it right 'cause this you know how deby business friendly.

peggy hamburg obama commissioner safeway usda obesity fda food safety walmart sixty five days
"fda" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

02:02 min | 3 years ago

"fda" Discussed on POLITICO's Pulse Check

"Which they pay to get their products reviewed and through fda faster and that money can really only go to those bray particular activities so fda really has a very small budget to do a lot of regulation a lot of overseeing of manufacturing facilities safety of food safety of drugs a lot of the public health task that fda does and the amount of staff they can afford to work on these issues is pretty limited and oftentimes the money than dictates priorities and what is sort of in law guaranteed paid for tax pay that's not taxpayer money that you don't have to fight congress for every year can always get done pretty efficiently and everything else its what can they do with a very small budget it's it's interesting you make the point because having joe spin up at fda talking to the commissioner the feeling of campus is so different than sapien jr which is also another important agency but feels kind of look at university and in his sprawling an interest has like more of a hightech fuel in places you're looking at me possibly sceptically so maybe i'm wrong but i wouldn't the that isn't like hightech in in some ways like the main campus in white out to me feels really big but again and ages budget i think is about thirty two billion now year again fda six and of course i'm not saying i don't know what the right number would be or how much nih does verses fda it's just they do a lot of public health where they have a lot of responsibilities and most people generally agreed they're doing out on like a shoestring budget was there anything else or withdrawal leaves said about the form of sides zero that you thought because her former reporter was worth calling out you're one of the things that struck me as really interesting you guys talked about puerto rico and the situation there with drug manufacturing and you kind of asked him bowl like what should be done for future scenarios and storms in puerto rico ally.

food safety congress joe commissioner nih public health reporter puerto rico bray
"fda" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

02:03 min | 3 years ago

"fda" Discussed on POLITICO's Pulse Check

"Over the course of this year is promulgating putting forward additional guidance um policy guidance that's going to allow us to make more information available at the time of recall so there's been some concern that when we recall a product we talk about the product in a manufacturer we give skew codes uh so people can identifier store shelf but if you happen to receive that product from a restaurant or a school or some other venue you might not know that you had to recalled product we think that we could provide more information we're going to look for ways to do that and so we're going to be doing taking additional steps of the course of this year to improve our recall process but i do think it has improved substantially from the time period that that report looked at you seemed to hint a statement after the idea report came out that fda might be naming which retailer sold recalled food usda already routinely does that you dealt are you going to be changing our policy of there well that's what i'm that's the policy guidance suggesting we're we're gonna look to provide more information around where you might have received a recalled product now remember usda does that because the product a meat product isn't identifiable by the meat product it's only identifiable by where the meat product came from a food product that we regulate most the food products we regulate i readily identifiable by the packaging you don't need to know the source of the product to know that you might have received the product so it's a different regulatory paradigm that that that said that's why there is a distinction between how fda has historically operate and how usda has but accepting that we are going to look at how we can provide more information around food recalls to that consumers who might have received a recalled product at a restaurant for example are able to know that they might have received it so we've talked about the food side let's switch back over to the the drug side of the brain and talking about all of the drugs that have been approved this has been a major success point but the flip side is there are concerns they may be too many medicines are getting through in this is the safety speed paradigm that fda always russel's with what what is the number of drug.

usda food products fda russel
"fda" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

02:02 min | 3 years ago

"fda" Discussed on POLITICO's Pulse Check

"Out break i those five reports of an outbreak that are unrelated to each other are those the first five reports of what are going to become hundreds maybe thousands of reports and you don't know where you are sometimes in the throes of of of of emergence like that of a poor like that um and that's that's why you need to focus on that you need to ask card questions you need to spend time on it you need make sure people are doing what they need to be doing we had such a report last week um hand gino again were its early days and we don't know are we at the beginning are we at the end is it related to one product is it just some sporadic reporting related to multiple products those are the patterns many to discern and and that's important function that the fda place um the way we do it has to make sure that people are doing what they need to be there is the ongoing question about fda getting food off shelves fast enough there is an inspector general's report just last month on this issue more than one hundred sixty five days to initiate or one hundred sixty five days to initiate a recall for salmonella contaminated nut butter what what does fda need in terms of resources power to move faster when there are products that might be contaminated lament may produce in perspective if i can um one one recall that isn't done appropriately are efficiently as one too many uh so we take this very seriously uh any any examination of our recall process where where there is evidence that we didn't move quickly enough especially with a potentially dangerous pathogen now that said this was an examination of thirty recalls conducted between 2012 and 2015 of literally thousands conducted over that time period and it was thirty of the most complex recalls sit thirty of the most difficult to execute recalls we clearly didn't do well uh we certainly didn't do as well as we should have do i think it's representative of the overall programme i do not i also think we have put in place and will contain a put in place a lot of process improvements to get even better one of the things we're going to be looking at doing.

gino salmonella representative one hundred sixty five days
"fda" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

01:47 min | 3 years ago

"fda" Discussed on POLITICO's Pulse Check

"Schumer's comes across in your dealings on capitol hill does that he you and your office it's a good question i i think that um there is a certain challenge to to sort of adopt the premise of your question in that and it it transcends any administration that policy often gets viewed through um some element of a political lands and so if you take the exact same policy and you do it in a republican administration reverses you do in a democratic administration it gets perceived differently and and you know to some some in some respect the press is guilty of this to a certain times they they look at things through a certain lands and so i think from from my standpoint you know where a lot of our the the important role we play is speaking directly to consumers to patients to providers i think we need to look for ways to transcend that that political filter uh to make sure that things aren't getting misjudged or or not perceived appropriately because have getting that communication right is a critic go aspect of a public health function i will say in my role as a reporter having written about alternatives to fda their critics in every sector some who say fda moves to fast some say to slow very few say just right but the current mood around fda is incredibly positive and that comes from folks who are progressives who are were liberals were not inclined to approve of hhs more broadly but like what they're seeing coming out of fda your role as commissioner i'm i'm curious i notes cliche to say that new two days are are the same in any big job but how do you a portion your schedule when you could be doing and touching so many different sectors of of the economy of the healthcare space uh l.

Schumer capitol hill reporter commissioner public health two days
"fda" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

02:08 min | 3 years ago

"fda" Discussed on POLITICO's Pulse Check

"I'm dead diamond this is pulse check and that was president donald trump criticising the fda in his first speech to congress in february 2017 so how is the fda doing now and what are they doing under president trump that's the focus of today's episode rough speak with scout got leap highprofile fda commissioner about his work last year and what lies ahead for his agency then after the break i'll be joined by politicos lena a miller each and sarah karlin smith cover food and drugs respectively to analyse gottlieb's tenure at the agency in his remarks on this podcast just reminder you can find pulse check on all of your favorite podcast apps you can find me the week of january eighth in san francisco at the jp morgan healthcare conference where i will be with quitting several podcast an i'll be around to meet with any leicester's i met de diamond a politico dot com if your thoughts are feedback about our show with that here's fda commissioner scott gutless what are we start with this fda approved more than a thousand new generics last year it approved the first gene therapies there are a lot of first in 2017 if you were picking the headline for this agency last year what would it be i think the two things and if you're looking back that are gonna be the most profound in terms of what we did that's going to have i think a transformational impact potentially transformational impact on areas is going to be um what we did with respect to sell an and uh cellbased rejected medicine trying to put in place a modern framework for how we're going to bring those products to market going forward in a way that's uh you provides for consumer safety um this is a field i think holds a lot of promise but it's early days uh and so i think we have the opportunity now to write the modern rules for how that's going to go forward and that's not to say there hasn't already been a lot of work that's been done has been an enormous amount of work that's been done going back many years in law the w work trying to develop the the modern framework for.

donald trump fda scout commissioner gottlieb san francisco leicester gene therapies president congress sarah karlin smith jp morgan healthcare scott gutless
"fda" Discussed on Psychedelic Salon

Psychedelic Salon

01:39 min | 3 years ago

"fda" Discussed on Psychedelic Salon

"With ptsd it's not that we had to argue to the fda there's a bunch of people with whom we actually had a um a a mother when we are doing the first mdma study say that her daughter had been raped at a young age and was mute and she was only 16 at she it was earlier that but you sixteen at the time and so we apply to the fda for an exception to enroll her the study and the fda said no we had to complete the study in adults first but there are so many drugs that are approved by the fda that are being used off label in kids that the fda now unless there's some real talks this city issue like sometimes with cancer drugs their requiring sponsors to come up with a plan for doing study and allison's so we're we're actually requesting a waiver to do with that we don't have to do studies between zero and eleven ages and the methods of measuring p to see are not validated in those ages anyway but we're going to be proposing twelve to seventeen we can already go down to eighteen and we've negotiated successfully that we don't have to start that study until after the drug is approved so there will be us another series of discussions and negotiations with fda on additional studies the other question that the fc is gonna want us to address is what about the fact that we have three mdma sessions we have these forty hours a therapy but some people might need a foursession in some people might be successfully treated.

ptsd fda allison mdma forty hours
"fda" Discussed on Psychedelic Salon

Psychedelic Salon

01:40 min | 3 years ago

"fda" Discussed on Psychedelic Salon

"This that where you're going with what you were just talking about no not really what i'm basically saying is we have to become big firm on so i'm saying we need to play the game i think working with the system working with the fda so maps is a nonprofit pharmaceutical company and we are negotiating with fda about the right to market mdma as a prescription medicine the the difference is that we're not out to maximize profits were out to maximize social benefit and so we're not try it we there's no for all the people that work with us we don't have nondisclosure agreements we don't have any kind of confidentiality there's no secrets they after protect so in many ways is the opposite of big pharma but it is playing by the same rules and trying to work with in the system that big pharma works within and there's so i think that's an important distinction the the other way to say it to is that once mdma it once maps makes empty main to a madison then what we wanna do is sell it as a madison it would be maps and we also want to sell it for a bit more than it costs us so that we can instead of constantly going to donors and saying give us money we're a rare nonprofit in that we're talking about having a product at the end and there's a program that the fda has there was ironically developed by signed into law by eager reagan so that if you're working with a drug that is off pat mdma was invented the 1912 by merck.

pharmaceutical company mdma nondisclosure agreements madison fda reagan merck
"fda" Discussed on Psychedelic Salon

Psychedelic Salon

01:40 min | 3 years ago

"fda" Discussed on Psychedelic Salon

"That tend to work more and women and not in man and didn't work whenever they used it for combat that mdma worked for related ptsd and mdma worked for complex ptsd and mdma worked for ptsd from accidents and so from the starting in two thousand to two thousand sixteen we completed a whole series of phase two pilot studies the purpose of which is to figure out how to design face three and face three or the pivotal studies that are required to make a drug into a madison so under member 29th two thousand sixteen we went before the fda for what's called an end of phase two meeting and we had incredible we treat at one hundred and seven people and we also had developed new relationships with the two groups of people that were crucial to our negotiations as i said we started this and 1980 sex and it was thirty years before the end to face to meeting and during that time some of the key people with fda that we had been working with had retired and so through a chance meeting that i had with john with the daughter of one of the people from fda who was subsequently a job at letran it frontier um we were able to get in touch with her father and other so we have several senior fda officials who worked at the division of psychiatry products were now consulting with us to help us work with fda and they've trained the people that are now in charge two of the division of psychiatry products.

mdma ptsd madison fda john thirty years
"fda" Discussed on Psychedelic Salon

Psychedelic Salon

02:06 min | 3 years ago

"fda" Discussed on Psychedelic Salon

"Be a legal psychedelic therapist so it took a six years from eighty six to ninety two to get the first protocol approved by the fda they rejected five protocols before then and it wasn't so much that are sixth protocol was way better than the others what happened was that the people at the fda that regulated psychedelic s switched in a new group took over in this new group decided that science over politics and they would permit psychedelic some marijuana research to start but it also happened is that i had tried to get into a clinical sake phd program to learn about how did you psychotherapy outcome research with mdma nobody would let me end this is the late nineteen 80s and so i was blocked i'd been since seventy two to eighty eight i'd been thinking this is what i want to do and now i can't do it so i decided to smoke some pot and think it over and it's it's a really good technique the many of us know when you're in a box to threat questioned your assumption so i was under the influence of pot iit was like i wanna do this i want to much too soon the science is being blocked by the politics maybe i should switch and study the politics so it is i wear am i gonna stay politics harvard kennedy school government i knew of a professor they're and so eventually i managed to talk to him i managed to get in so i have this masters impeach d from the kennedy school government with a focus on the regulation of the medical use of second alex and while i was there for my master's i got home what's called the presidential management fellowship for people want a career in the federal government i kind of thumb managed to use the credibility of the kennedy school and get into this program and i have done i tried to get a job at the fda and and you can see how i'm dress now which is how i like to be addressed but i was willing to give up drugs wear a suit and go into work at the fda.

fda professor kennedy school marijuana mdma harvard kennedy school alex six years