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Mar 13, 2021
03/21
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fda concurred with both. the globalization of drug manufacturing recent fda with new challenges many of which have been exasperated by the pandemic. while the agency has taken steps to adapt, further action will be needed to ensure it can continue to fulfill its oversight responsibilities in the future. thank you, chairman bishop, ranking member fortenberry, and members of the subcommittee for holding this important hearing. this concludes my prepared remarks and i'm happy to respond any questions you may have. >> the hearing will start at the order of seniority. after that i will recognize members who were not present at the time the hearing was called to order. each member will have five minutes in each round to please be mindful of your time. at this time i will yield to myself for the first round of questions. i tell you what, i will defer my questions to the chair of the full committee, ms. delauro, and i will follow mr. fortenberry who will follow ms. delauro. >> hanky very, very much mr. chairman. and
fda concurred with both. the globalization of drug manufacturing recent fda with new challenges many of which have been exasperated by the pandemic. while the agency has taken steps to adapt, further action will be needed to ensure it can continue to fulfill its oversight responsibilities in the future. thank you, chairman bishop, ranking member fortenberry, and members of the subcommittee for holding this important hearing. this concludes my prepared remarks and i'm happy to respond any...
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Mar 13, 2021
03/21
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gao has included the fda on the high risk series since 2091 of the main problems fda gives foreign drug manufacturers but not american ones advance notice of inspections 12 weeks of advanced notice and i and they will fabricate that or secretly repeat test before the fda inspectors arrive. by contrast investigators have find evidence that they could not hide important records tossed in the trash bin birds or insect infestations even urine puddles on the floor clearly that is not a safer sterile manufacturing area. these shoddy practices resulting drugs with unimproved ingredients toxic impurities dangerous particulates making their way into american medicine cabinets in 2007 and 2008 hundreds of americans died from contaminated heparin and anticoagulant drug manufactured overseas and in 2018 andnd 2019, dozens of blood pressure drugs were recalled because it contained more than 200 times the acceptable limit of a known carcinogen because of the pandemic the fda has stopped all overseas inspections and unfortunately this means the fda work to prevent potentially tainted drugs from enteri
gao has included the fda on the high risk series since 2091 of the main problems fda gives foreign drug manufacturers but not american ones advance notice of inspections 12 weeks of advanced notice and i and they will fabricate that or secretly repeat test before the fda inspectors arrive. by contrast investigators have find evidence that they could not hide important records tossed in the trash bin birds or insect infestations even urine puddles on the floor clearly that is not a safer sterile...
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Mar 22, 2021
03/21
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anthony fauci, we will not get ahead of the fda. the fda has incredibly rigorous scientific process. as we would certainly encourage this, we would like to see that we have a rigorous process that will come and once a nearly cemented that will give us all more information and the reason to be comfortable. next. andy: let's go to jeremy diamond it with cnn. reporter: thank you. first of all, i am wondering we have been between 5,458,000 new daily cases for the last two weeks printed this morning about the essential risk and that home or are you to encourage states to maintain rainbows that coronavirus restrictions rather than relaxing them testimony hard and secondly, do still expect johnson & johnson to deliver 20 million doses by the end of the month which is just a week away now. thank you. andy: would you like to take the first question doctor walensky partied and things that we can be doing as a country. walensky: yes, i would be happy to. we are looking at the data and reaching out to individual states trying to encourage them
anthony fauci, we will not get ahead of the fda. the fda has incredibly rigorous scientific process. as we would certainly encourage this, we would like to see that we have a rigorous process that will come and once a nearly cemented that will give us all more information and the reason to be comfortable. next. andy: let's go to jeremy diamond it with cnn. reporter: thank you. first of all, i am wondering we have been between 5,458,000 new daily cases for the last two weeks printed this morning...
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Mar 23, 2021
03/21
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the fda has incredibly rigorous scientific process. so while we would certainly call , today's news encouraging, it's the kind of thing we like to see, we have a rigorous process that will come once an eua is submitted, and that will give us all more information and reason to be comfortable. next question. >> let's go to jeremy diamond at cnn. reporter: hey, thanks for doing the briefing as always. first of all, i'm wondering, we have been between 54000 and 58,000 new daily cases over the last two weeks. you guys are warning about the potential risks in that. what more are you doing to encourage states to maintain or reimpose coronavirus restrictions rather than relaxing them as so many are? secondly, do you still expect johnson & johnson to deliver 20 million doses by the end of the month, which is just a week away now? thanks. andy: dr. walensky, would you like to take the first question about the kind of flattening of case rates and things that we can be doing as a country? dr. walensky: yeah, i'd be happy to. we are looking at thes
the fda has incredibly rigorous scientific process. so while we would certainly call , today's news encouraging, it's the kind of thing we like to see, we have a rigorous process that will come once an eua is submitted, and that will give us all more information and reason to be comfortable. next question. >> let's go to jeremy diamond at cnn. reporter: hey, thanks for doing the briefing as always. first of all, i'm wondering, we have been between 54000 and 58,000 new daily cases over the...
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Mar 19, 2021
03/21
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hawn at the fda led last year. lean on your private sector partners, commercial labs, academic centers, large scale test makers to rapidly develop diagnostics that serve as one great asset during an outbreak of an emerging and infectious disease. the same is true of the surveillance system. last week dr. jha from brown university said we need, quote, a new approach to our surveillance. we discussed leveraging data sets like weather patterns and mobility information alongside traditional testing and patient data from health care providers. we need a surveillance system in partnership with the private sector, states and local public health experts to get a true picture of the threats on the ground. the covid relief packages have given cdc billions of dollars to modernize these systems. the cdc must not hoard that money for yourselves. instead, use these funds to identify technologies that better equip us. imimplore you to not build internal systems that only become obsolete before they even get up and running. dr. fa
hawn at the fda led last year. lean on your private sector partners, commercial labs, academic centers, large scale test makers to rapidly develop diagnostics that serve as one great asset during an outbreak of an emerging and infectious disease. the same is true of the surveillance system. last week dr. jha from brown university said we need, quote, a new approach to our surveillance. we discussed leveraging data sets like weather patterns and mobility information alongside traditional testing...
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Mar 29, 2021
03/21
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CNNW
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the private sector was supposed to work with the fda to develop that. >> but the fda added another stephey asked labs to apply forage emergency use authorization or eua to bring their tests to market during a public health emergency. something many labs never had to do before. >> declaration of a public health emergency allows us to use our emergency use authorization authority. that allowed us to use a different, if you will, evidentiary standard and regulatory standard to authorize products. >> that did exhibit the private sector from coming in and the academic sector from coming in because that's not something they really were used to. >> we heard this over and over again. we've got this great alternative. we can't get the fda to pay attention. were those fair criticisms? >> upwards of 60% of the tests that we reviewed had problems with them. and, so, the question is do you want tests that are on the market just so you can get tests on the market, or do you want there to be some oversight to ensure the specificity and accuracy is appropriate? >> in the meantime, in addition to that w
the private sector was supposed to work with the fda to develop that. >> but the fda added another stephey asked labs to apply forage emergency use authorization or eua to bring their tests to market during a public health emergency. something many labs never had to do before. >> declaration of a public health emergency allows us to use our emergency use authorization authority. that allowed us to use a different, if you will, evidentiary standard and regulatory standard to...
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Mar 20, 2021
03/21
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KDTV
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. >> la vocera de la fda nos dice por quÉ es posible que estÉ hay un lugar auténtico que se nos antojatillo cuenta una historia. donde cacique inspira la chispa. para contar una historia a nuestra manera. cacique. lo auténtico los espera. este aparato desconectado está protegiendo nuestras bellas costas y más. usa menos energía dejando a un lado tus tareas domésticas de 4 a 9 p.m., y así ayuda a que nuestro estado siga brillando. paola: la policÍa de san francisco busca ayuda de los residentes para identificar a un hombre que el 3 de octubre del aÑo pasado empujo a una persona del autobÚs. la vÍctima permanece hospitalizada con una lesiÓn cerebral. se describe al sospechoso como un hombre de color de unos 20 aÑos que estaba acompaÑado por una mujer que vestÍa prenda de color rojo y una mochila. si usted es de las personas que acostumbra utilizar productos para alisar su cabello, preste atenciÓn porque la fda advirtiÓ que hay un ingrediente que podrÍa causar daÑos irreversibles a su salud, entre ellas enfermedades como el cÁncer. nuestra colega en su reporte nos explica. presentadora: e
. >> la vocera de la fda nos dice por quÉ es posible que estÉ hay un lugar auténtico que se nos antojatillo cuenta una historia. donde cacique inspira la chispa. para contar una historia a nuestra manera. cacique. lo auténtico los espera. este aparato desconectado está protegiendo nuestras bellas costas y más. usa menos energía dejando a un lado tus tareas domésticas de 4 a 9 p.m., y así ayuda a que nuestro estado siga brillando. paola: la policÍa de san francisco busca ayuda de...
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Mar 19, 2021
03/21
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last month, fda issued new guidance and an up date to fda guidance on variants.y issuing these, we want the american public to know we are using every tool at our disposal to fight this pandemic, including pivoting as the virus adapts. these guidances will help manufacturers develop medical products and provide health care providers with the best diagnostics, therapeutics and vaccines to fight this virus as variants emerge. we remain committed to getting these life-saving products to front lines. i would like to stress that having read vaccines authorized by fda only one year after declaration of the pandemic is a tremendous achievement and a testament to the dedication of a multitude of partners. these include fda career scientists and physicians, who have been working tirelessly to conduct rigorous evaluation of data submitted for vaccines to prevent covid-19. all of us at the agency are grateful to contribute toward bringing this >> thank you, dr. marks. i will turn to dr. walensky. >> thank you, ranking member, for your invitation to talk to you today and for
last month, fda issued new guidance and an up date to fda guidance on variants.y issuing these, we want the american public to know we are using every tool at our disposal to fight this pandemic, including pivoting as the virus adapts. these guidances will help manufacturers develop medical products and provide health care providers with the best diagnostics, therapeutics and vaccines to fight this virus as variants emerge. we remain committed to getting these life-saving products to front...
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Mar 22, 2021
03/21
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CSPAN2
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compounded drugs are not fda approved most of the time.they didn't, they just suspected like most of us do if you are getting a drug at a doctor's office or hospital in the united states that it is fda approved and that just is not always the case. one of the big takeaways from this is that compounding is clearly in important part of the pharmaceutical supply chain. when you allow it to occur like it did in this case and others since then you're going to have these type of problems occur so it's important that people are aware that these products are out there in the system. and if they are concerned about it, they ask about it. >> your book talks about the law such as they are, the regulations such as they are what is required to be purported i mentioned this to you early earlierbefore our talk today. michigan watchers will also know the appearance of the late great john dingell and of course i should practice this question with a little knowledge for people. this book as i said stands several years of time and it did take quite a while f
compounded drugs are not fda approved most of the time.they didn't, they just suspected like most of us do if you are getting a drug at a doctor's office or hospital in the united states that it is fda approved and that just is not always the case. one of the big takeaways from this is that compounding is clearly in important part of the pharmaceutical supply chain. when you allow it to occur like it did in this case and others since then you're going to have these type of problems occur so...
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Mar 22, 2021
03/21
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fda. fda. pfizer, moderna and johnson & johnson, and more vaccine candidates are in clinical trials. two of the witnesses come dr. fauci and doctor marx played important roles in this achievement. one of vaccine bullet was slow to start is vaccine backs -- supply and distribution has continued to improve since the first vaccines were authorized, distributed and administered in december. according to the centers for disease control and prevention nearly 22% of the u.s. population has received at least one dose of a covid-19 vaccine and almost 12% of u.s. population is fully vaccinated. this means more people have been vaccinated than have been infected with the virus in the u.s. we still have an ways to go but we are in remarkable situation given we are only a little year out from the start from this global pandemic. recently the subcommittee held two metrics focus on covid-19 vaccines. unfed resected the suddenly heard from a hateful states about vaccine distribution and administration efforts
fda. fda. pfizer, moderna and johnson & johnson, and more vaccine candidates are in clinical trials. two of the witnesses come dr. fauci and doctor marx played important roles in this achievement. one of vaccine bullet was slow to start is vaccine backs -- supply and distribution has continued to improve since the first vaccines were authorized, distributed and administered in december. according to the centers for disease control and prevention nearly 22% of the u.s. population has...
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Mar 16, 2021
03/21
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we have been working around the clock and what i got the fda to do, this would not have happened.s would have happened many, many years from now if i didn't get involved and if we didn't get involved. >> maria: tell me more about that. i remember you were talking about when you were in office, you were talking about the meeting that you held with the major pharmaceutical company heads and you were garnering all of their support to work together to ensure that a vaccine was on the market as soon as possible and you said that one issue that you were trying to do was to alleviate any bureaucracies within the fda. how was it that you were able to encourage a vaccine on the market within 9 months? that was quite extraordinary. >> well, i wouldn't say the fda -- go i push them very hard, heart of the end they have ever been pushed and a number of the people in the fda admitted that and at the end, they were very happy. but they did not, they wanted to announce it sometime after the election because they just, i think most people knew we pretty much have the vaccine before the election.
we have been working around the clock and what i got the fda to do, this would not have happened.s would have happened many, many years from now if i didn't get involved and if we didn't get involved. >> maria: tell me more about that. i remember you were talking about when you were in office, you were talking about the meeting that you held with the major pharmaceutical company heads and you were garnering all of their support to work together to ensure that a vaccine was on the market...
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Mar 3, 2021
03/21
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guest is alex gorsky, a company this week the third to receive emergency use authorization from the fdasell its vaccine in the u.s., johnson & johnson. we want to in this period shed some light on complicated questions and learn from mr. gorsky how he sees this rollout moving forward. thank you so much, alex, for joining us today. >> well, david, it's a real pleasure to be here and thank you for having us. >> so, let's begin with the amazing announcement yesterday na you're going to partner with merck, one of your biggest competitors to produce your j&j vaccine in sufficient volumes. tell us how that agreement came to be. president biden described it as the type of collaboration between companies that we saw in world war ii. it certainly is unusual. tell us how it happened. >> well, david, you're right. these are unusual times to say the least and you know, we felt that given everything that's occurred with the virus, the unexpected twists and turns, the surges that we've seen, the rising observation of variants and mutations, that it's absolutely necessary for us not only as a country,
guest is alex gorsky, a company this week the third to receive emergency use authorization from the fdasell its vaccine in the u.s., johnson & johnson. we want to in this period shed some light on complicated questions and learn from mr. gorsky how he sees this rollout moving forward. thank you so much, alex, for joining us today. >> well, david, it's a real pleasure to be here and thank you for having us. >> so, let's begin with the amazing announcement yesterday na you're...
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Mar 13, 2021
03/21
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CNNW
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but mostly i want to give the fai fda the flexibility. in two or three week, there will are more data. >> and the "wall street journal" has been covering your idea. and they quoted a senior scientist and adviser to president biden who said that you'd be flying blind to just use one dose if you are going to do something else other than follow the study shown to the fda, show me that this one shot effect is durable. in doing research, the best that could i find was alert to the editor of the journal of medicine. is that the best in terms of study or research that you are able to point to? >> look, i don't think what it will be like in six months or nine months from now. but i think that it will be sufficient protection until we have enough to get the second vaccine into everybody. and i think what i'm seeing shows that over a month, two months of the effectiveness it goes up more from just one shot. so i think that there is enough real data out there that the fda should seriously consider the best way to use this finite r resource. >> and y
but mostly i want to give the fai fda the flexibility. in two or three week, there will are more data. >> and the "wall street journal" has been covering your idea. and they quoted a senior scientist and adviser to president biden who said that you'd be flying blind to just use one dose if you are going to do something else other than follow the study shown to the fda, show me that this one shot effect is durable. in doing research, the best that could i find was alert to the...
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Mar 23, 2021
03/21
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congress passed legislation that will improve and streamline the fda approval process for new forms of insulin which should usher in more competition into a category that has seen huge and unwarranted price increases. at a hearing of the cost of insulin, a father testified that insulin for his son had tripled in price, forcing him to purchase from canada, similar to it the chairman has described. the cost of insulin is one of the most prominent examples and i am grateful a constituent of the chairman is here to share the story. as cochair of the diabetes caucus which i founded in 1998, senator shaheen and i introduced legislation to create a new pricing model for insulin which was first started a century ago in canada and has soared in price. recently we have seen nascent steps on insulin availability. more than 1700 medicare advantage plans have agreed to cap monthly co-pays for insulin at $35. manufacturers are adding more affordable options such as eli lilly's $35 co-pay program which has been available during the pandemic. these are good first steps but i hope we can do much more.
congress passed legislation that will improve and streamline the fda approval process for new forms of insulin which should usher in more competition into a category that has seen huge and unwarranted price increases. at a hearing of the cost of insulin, a father testified that insulin for his son had tripled in price, forcing him to purchase from canada, similar to it the chairman has described. the cost of insulin is one of the most prominent examples and i am grateful a constituent of the...
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Mar 21, 2021
03/21
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fda has provided emergency use authorization or eua for short for three covid-19 vaccines. in doing so, we've relied upon the agency's rigorous standards for safety, effectiveness and manufacturing quality. though there may be some differences in the results obtained using the three covid-19 vaccines it should be noted they were not compared in a head-to-head clinical trial. all three were found by fda and its external advisory committee to exceed the standards for an eua that we articulated in guidance and importantly all did an excellent job in preventing hospitalization and death from covid-19. following vaccine authorization approval fda works with manufacturers to help ensure continued supply and availability of these critical products. the agency does this by reviewing proposed technical or manufacturing changes and monitoring the continued quality of the products. fda recently reviewed and -- the data submitted by pfizer to allow undiluted frozen files of the vaccine to be transported and stored at conventional temperatures found in pharmaceutical freezers for two we
fda has provided emergency use authorization or eua for short for three covid-19 vaccines. in doing so, we've relied upon the agency's rigorous standards for safety, effectiveness and manufacturing quality. though there may be some differences in the results obtained using the three covid-19 vaccines it should be noted they were not compared in a head-to-head clinical trial. all three were found by fda and its external advisory committee to exceed the standards for an eua that we articulated in...
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Mar 4, 2021
03/21
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>> i think is likely to occur within timeline, the fda is already working with companies to establishthe clear regulatory guidelines so the appropriate data can be collected and again, i know all the companies are working and in our case for particular helpful because our vector platform that we were using for the 26 was used extensively among broad age agroups young and old when we e developing this for other conditions such as ebola and hiv, gives us reasons to be optimistic regarding the states profile and that patient population, we still have to do the clinical work but i would be hopeful ine that timeframe near the end of this third quarter and into the fourth quarter that hopefully we can get that information to demonstrate safety and efficacy in adolescents and children. >> let's talk about the casey which is one of the puzzles for the public your new one dose vaccine has been estimated to be roughly 70%e effective overall but it works by numbers 85% ofse the time against severe disease and 100% effective in present and her preventing hospitalization and death. i think the que
>> i think is likely to occur within timeline, the fda is already working with companies to establishthe clear regulatory guidelines so the appropriate data can be collected and again, i know all the companies are working and in our case for particular helpful because our vector platform that we were using for the 26 was used extensively among broad age agroups young and old when we e developing this for other conditions such as ebola and hiv, gives us reasons to be optimistic regarding...
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Mar 28, 2021
03/21
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FBC
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right now we also don't have a full-time commissioner but there's also the concern that the fda mayricter under the new administration, this has affected a number of biotech and pharma names over the last week several downgraded including alexion pharmaceutical. jack: thank you for that, i'm hoping the mrna breakthrough in the search for the vaccine will yield great development for great drugs as well. coming up during the pandemic electronic signatures allow businesses to keep on turning. businesses to keep on turning. dan springer come on, come on...yes! hey ava, how's my bracket looking? um, i'm trying to find a nicer word for dumpster fire. um, you're not ava. yeah, this is gary, i invested in invesco qqq. a fund that invests in the innovations of the nasdaq-100. like this artificially intelligent home system. you don't have to be an ai voice architect to help dictate the future. any other questions? yes, when will you be leaving? become an agent of innovation with invesco qqq. ♪ ♪ ♪ become an agent of innovation with invesco qqq. it's a wishlist on wheels. a choice that require
right now we also don't have a full-time commissioner but there's also the concern that the fda mayricter under the new administration, this has affected a number of biotech and pharma names over the last week several downgraded including alexion pharmaceutical. jack: thank you for that, i'm hoping the mrna breakthrough in the search for the vaccine will yield great development for great drugs as well. coming up during the pandemic electronic signatures allow businesses to keep on turning....
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Mar 31, 2021
03/21
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KGO
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so, what this could now mean as pfizer looks to the fda for approval.umbers tonight. 97,226,000 people have now received at least one dose, approaching 38% of adults in this country. but cases are on the rise and more than half the country tonight and the cdc director's new warning this evening. there is also late word coming in tonight, a new headline breaking involving the johnson & johnson one-shot vaccine. here's abc's stephanie ramos now. >> reporter: tonight, a major step toward getting millions of children vaccinated by the fall. pfizer reporting its vaccine was 100% effective in children ages 12 to 15. none of the children who got the real vaccine developed covid-19. >> this is, like, really aeffic. so, we got to have the fda do the full evaluation, but i think this is terrific. >> reporter: 12-year-old caleb chung doesn't know if he got the vaccine or a placebo, but he wanted to be apart of the trial. >> potentially helping other kids to feel safe and want to get the vaccine in the future when it becomes publicly available was really some way t
so, what this could now mean as pfizer looks to the fda for approval.umbers tonight. 97,226,000 people have now received at least one dose, approaching 38% of adults in this country. but cases are on the rise and more than half the country tonight and the cdc director's new warning this evening. there is also late word coming in tonight, a new headline breaking involving the johnson & johnson one-shot vaccine. here's abc's stephanie ramos now. >> reporter: tonight, a major step toward...
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Mar 18, 2021
03/21
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CSPAN2
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fda has emergency use authorization for covid-19 vaccines. in doing so we've relied upon the manufacturing quality family vaccine development can minimize risk and then through the various stages of development and manufacturing scale only takes place when it's clear it is shown to be safe and effective on track for regulatory approval. without cutting quarters are sacrificing standards with intensive interaction eliminating the time with the clinical development process merging together trials and then before it was clear the vaccine could be shown to be safe and effective while clinical trials were ongoing. not only including a thorough evaluation but also included independent scientific public health experts during the advisory committee. throughout the process including posting briefing documents in key decisional memoranda the three authorizations make available vaccines in the united states clear and compelling efficacy in large well-designed safety trials to meet the standards for safety and effectiveness that will help in the fight of
fda has emergency use authorization for covid-19 vaccines. in doing so we've relied upon the manufacturing quality family vaccine development can minimize risk and then through the various stages of development and manufacturing scale only takes place when it's clear it is shown to be safe and effective on track for regulatory approval. without cutting quarters are sacrificing standards with intensive interaction eliminating the time with the clinical development process merging together trials...
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Mar 1, 2021
03/21
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the one that was just approved by the fda echo -- fda? rachana: i will say that a lot of these pharmaceutical companies in general can be involved in lawsuits either related to, i'm not sure they're involved in one related to vaccine production, but it certainly not on the homily for a large corporation to be embroiled in various legal disputes. i'm not sure i can speak directly to that. the one thing i did want to highlight for your earlier question related to pfizer and moderna, the data from clinical trials that was the basis for the authorization that came from the fda found that the pfizer and moderna vaccine's are essentially similar as far as levels of effectiveness in preventing symptomatic covid-19 disease. host: the gao tells us operation warp speed has spent 12 billion dollars, close to $13 billion when it comes to the development and manufacturing of vaccines. $2 billion for therapeutic development -- when it comes to companies involved, one billion going to johnson & johnson, 1.2 million for moderna and astrazeneca. pfizer, $
the one that was just approved by the fda echo -- fda? rachana: i will say that a lot of these pharmaceutical companies in general can be involved in lawsuits either related to, i'm not sure they're involved in one related to vaccine production, but it certainly not on the homily for a large corporation to be embroiled in various legal disputes. i'm not sure i can speak directly to that. the one thing i did want to highlight for your earlier question related to pfizer and moderna, the data from...
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Mar 22, 2021
03/21
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BBCNEWS
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i think the fda, _ christian, i love that. i think the fda, it's— christian, i love that., it's internal and external review— fda, it's internal and external review groups of experts, and they're — review groups of experts, and they're very tough, are going to look_ they're very tough, are going to look at — they're very tough, are going to look at this vaccine quickly. we'll see how— look at this vaccine quickly. we'll see how much we can utilise, and if we have _ see how much we can utilise, and if we have extra, i would be in the front— we have extra, i would be in the front of— we have extra, i would be in the front of the _ we have extra, i would be in the front of the line telling our government we sit, get it out, get it out— government we sit, get it out, get it out into — government we sit, get it out, get it out into the world so that it can prevent _ it out into the world so that it can prevent disease. gne it out into the world so that it can prevent disease.— prevent disease. one of the criticisms — prevent disease. one of the criticisms on _ prevent disease.
i think the fda, _ christian, i love that. i think the fda, it's— christian, i love that., it's internal and external review— fda, it's internal and external review groups of experts, and they're — review groups of experts, and they're very tough, are going to look_ they're very tough, are going to look at — they're very tough, are going to look at this vaccine quickly. we'll see how— look at this vaccine quickly. we'll see how much we can utilise, and if we have _ see how much we can...
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Mar 1, 2021
03/21
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FOXNEWSW
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when you look at warp speed, i was strongly with the fda. and fda is you know, strong body of people. most of them have been there a long time. they are very much engrained. they have a way of doing things, take at least 5 years for a vaccine, i would not have it i went to meetings and process, we took a risk, i think an educate educatedbet, we started making s before we knew they were really work, it would have delayed for months if we did not do that we put our money where our mouth was, we got vaccine made, early, with process took 9 months. and this was something that was supposed to take 4 or 5 years, the outcome was different, we put up presearch money, and research and development money, i don't think that drug companies would have done without us, we came up with a vaccine, it is being credited one of the great miracles of medicine, it saved we talk about the number of lives, i think saved just tens of millions of lives this the world. been a success, and vaccines are working. we got them out fast, up to a million 5 a day, we're prou
when you look at warp speed, i was strongly with the fda. and fda is you know, strong body of people. most of them have been there a long time. they are very much engrained. they have a way of doing things, take at least 5 years for a vaccine, i would not have it i went to meetings and process, we took a risk, i think an educate educatedbet, we started making s before we knew they were really work, it would have delayed for months if we did not do that we put our money where our mouth was, we...
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Mar 28, 2021
03/21
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CSPAN
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eye 23
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from 2010 to 2019, the fda approved 356 drugs. it was a cost to the taxpayer of roughly $230 billion. in spite of this contribution, the nih is listed on only 27 of those patents. this suggests that while taxpayers provide funding for the bulk of the early-stage research, they do not get patent protection, supposedly secured by the act. in essence, american taxpayers are paying the highest prices in the world for drugs they already paid to help develop. dr. kesselheim, our american taxpayers getting a fair dear al for this research investment, and how should we be looking at examining the taxpayer contribution, and what would this mean for drug prices if we got it right? dr. kesselheim: i think americans getting advantages with the products that are developed by public funding and a bleeding two important new treatments -- end up leading to important new treatments like the covid-19 vaccines or other transformative drugs. research from our group has shown that by far transformative drugs are much more likely to come out of public
from 2010 to 2019, the fda approved 356 drugs. it was a cost to the taxpayer of roughly $230 billion. in spite of this contribution, the nih is listed on only 27 of those patents. this suggests that while taxpayers provide funding for the bulk of the early-stage research, they do not get patent protection, supposedly secured by the act. in essence, american taxpayers are paying the highest prices in the world for drugs they already paid to help develop. dr. kesselheim, our american taxpayers...
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Mar 31, 2021
03/21
by
KSTS
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eye 84
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por el momento están esperando la aprobación de la fda.resultado tarda entre 30 a 40 minutos. el director ejecutivo de la empresa dice que la fda podría tardarse entre seis hasta ocho semanas para darle luz verde al producto. >> (habla en inglés). >> si llega al mercado, el doctor dice que las pruebas se pueden obtener en farmacias y se pueden distribuir a negocios, universidades y lugares de trabajo. además que pueden detectar otras variantes del virus. la meta eventualmente es que la prueba rápida este disponible sin restricción, pruebas de coronavirus que podrían ser parte de nuestras vidas por varios años más. >> cambiamos de tema y vamos a nicaragua donde el tradicional viacrucis acuático en la costa de granada se hizo este año sin multitudes ni líderes religiosos. recorrieron varias balsas con feligreses. hicieron una petición especial de acabar con la pandemia y lograr paz en el país especialmente cerca de las elecciones presidenciales. otros eventos fueron cancelados para evitar aglomeraciones. nos centros de control de enfermedade
por el momento están esperando la aprobación de la fda.resultado tarda entre 30 a 40 minutos. el director ejecutivo de la empresa dice que la fda podría tardarse entre seis hasta ocho semanas para darle luz verde al producto. >> (habla en inglés). >> si llega al mercado, el doctor dice que las pruebas se pueden obtener en farmacias y se pueden distribuir a negocios, universidades y lugares de trabajo. además que pueden detectar otras variantes del virus. la meta eventualmente...
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27
Mar 27, 2021
03/21
by
FBC
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eye 27
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right now we also don't have a full-time commissioner but there's also the concern that the fda mayricter under the new administration, this has affected a number of biotech and pharma names over the last week several downgraded including alexion pharmaceutical. jack: thank you for that, i'm hoping the mrna breakthrough in the search for the vaccine will yield great development for great drugs as well. coming up during the pandemic electronic signatures allow businesses to keep on turning. businesses to keep on turning. dan springer it's game time, let's meet the defending champs. g. hargrave thomas, point guard. bryce matthias, forward. kim kietz, investor. oh, i invested in invesco qqq. a fund that invests in the innovations of the nasdaq-100. like next gen 3d rendering software. you don't have to be an advanced graphics architect to help realize a more vibrant future. become an agent of innovation with invesco qqq. ♪ allergies don't have to be scary. spraying flonase daily stops your body become an agent of innovation with invesco qqq. from overreacting to allergens all season lo
right now we also don't have a full-time commissioner but there's also the concern that the fda mayricter under the new administration, this has affected a number of biotech and pharma names over the last week several downgraded including alexion pharmaceutical. jack: thank you for that, i'm hoping the mrna breakthrough in the search for the vaccine will yield great development for great drugs as well. coming up during the pandemic electronic signatures allow businesses to keep on turning....
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22
Mar 31, 2021
03/21
by
CSPAN
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eye 22
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fauci as he always does will help the public interpret whatever comes out of the fda when they review the data. people should be very assured that we have the best regulatory bodies to study these matters in the world. we will be looking at this data and the best scientists in the world will help people understand whatever comes out of that. we should wait until we see whatever happens with that process before anyone jumps to conclusions. next question. >> jeremy at cnn. >> can you hear me? thank you. two questions. first, you said you expected the variant to be dominant in the u.s. by the end of march or early april. is it now the dominant strain and how many increase in cases you attribute to that. ? second, we heard about the importance of keeping or reinstating mask mandates but several places with the worst surges have not done away with their mandates. my question is, what are you telling states about which restrictions they should be implementing and why haven't you published uniform gating criteria to layout roadmap that they should be following? dr. walensky: as i mentioned e
fauci as he always does will help the public interpret whatever comes out of the fda when they review the data. people should be very assured that we have the best regulatory bodies to study these matters in the world. we will be looking at this data and the best scientists in the world will help people understand whatever comes out of that. we should wait until we see whatever happens with that process before anyone jumps to conclusions. next question. >> jeremy at cnn. >> can you...
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77
Mar 22, 2021
03/21
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CSPAN
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eye 77
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at some point, the results of the studies will be submitted to the fda. the fda will do its thing and make a recommendation and we will be ready from an operations perspective to rollout the vaccines and make sure kids are getting vaccinated. so i don't know if i have a cristobal here, chelsea, but i can tell you that we will be ready, as the data involves, as the fda and the cdc do what they usually do to be able to rollout the vaccine. same way we have done with j&j. we waited as the fda and the cdc were evaluating the results of the studies. we got ready to roll out the vaccines, and we were able to roll it out the following day after it was approved to start shipping. i think the most important part is to make sure everybody is getting vaccinated when their turn is coming. we are creating so many opportunities for people to get vaccinated, whether it is at federal retail pharmacies, whether it is at community vaccination centers, we mentioned the one in new york, there are many of those across the country, actually 600 across the country. we are worki
at some point, the results of the studies will be submitted to the fda. the fda will do its thing and make a recommendation and we will be ready from an operations perspective to rollout the vaccines and make sure kids are getting vaccinated. so i don't know if i have a cristobal here, chelsea, but i can tell you that we will be ready, as the data involves, as the fda and the cdc do what they usually do to be able to rollout the vaccine. same way we have done with j&j. we waited as the fda...
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the fda issues that alert about the thermal scanners. we have seen them now at airports, officers, schools, restaurants to check your temperature. checking for fevers in this pandemic. what was the alert? >> reporter: david, the fda is warning that improper use of those thermal scanners could pose a danger to public health. it could be an effective tool, but could give an inaccurate temperature reading for a variety of reasons. the fda says the risk is more likely when they're running multiple people through at one time. >>> in the meantime as americans wait for vaccinations, the millions waiting for economic help. the debate under way tonight in the senate over president biden's plan that includes those $1,400 checks, and there is news tonight on the debate over unemployment benefits, how much and for how long. rachel scott with late reporting tonight from the hill. >> reporter: tonight, president joe biden pushing lawmakers to get moving as the senate wrangles over his $1.9 trillion covid rescue plan. >> at least 7,000,000 kids don't h
the fda issues that alert about the thermal scanners. we have seen them now at airports, officers, schools, restaurants to check your temperature. checking for fevers in this pandemic. what was the alert? >> reporter: david, the fda is warning that improper use of those thermal scanners could pose a danger to public health. it could be an effective tool, but could give an inaccurate temperature reading for a variety of reasons. the fda says the risk is more likely when they're running...
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48
Mar 26, 2021
03/21
by
KNTV
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eye 48
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they can help with allergies but the fda is concerned that the fda is misusing or mislabeling nasal decongestants. misuse can lead to serious problems such as high blood pressure, heart problems and cr design changes that would prevent tampering and also they are asking them to decrease the amount of medicine in the inhalers. >>> ten out of ten parents agree every time a baby is born it's a pretty manley call moment. >> but "today's" show hoda kotb has the story of a new hampshire couple's baby whose birth this past week was truly miraculous. >> it was a birth that beat the odds. 57-year-old barbara higgins delivered a healthy baby boy on saturday, becoming one of the oldest women to give birth in the u.s. >> i'm 57. the whole thin honestly. >> reporter: barbara and her husband kenny welcoming baby boy jack. >> i'm so proud of her. >> reporter: she says the pregnancy, her third, was easy thanks in part to her active lifestyle, but getting pregnant later in life comes with challenges. barbara's doctor monitored her closely. >> a lot of blood work and visit, ultrasounds, things we would do for anyo
they can help with allergies but the fda is concerned that the fda is misusing or mislabeling nasal decongestants. misuse can lead to serious problems such as high blood pressure, heart problems and cr design changes that would prevent tampering and also they are asking them to decrease the amount of medicine in the inhalers. >>> ten out of ten parents agree every time a baby is born it's a pretty manley call moment. >> but "today's" show hoda kotb has the story of a...
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179
Mar 13, 2021
03/21
by
FOXNEWSW
tv
eye 179
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and an fda issued a warning against using this to treat covid-19.barrassing admission. they have not reviewed data of the covid-19 patients to treat or to prevent covid-19. joining me now is a man's testimony, president and chief medical officer of the frontline covid critical care alliance, dr. pierre kory this is wildly rep and this wasn't of heidrick hydric clocks of corn. but the fda has to come out against therapeutics because otherwise the directive for the vaccine wouldn't make as much sense or would it? >> there is a number of theories why they are doing it but all i know is they are doing it. but i want to point out this has nothing to do with hydroxychloroquine and peer that was medicine that was adopted widely before there was any trials. and this is the opposite. we are sitting on a mountain of evidence and yet, they are still still telling us not to use it and approve it. it is really inexplicable. i don't understand one of the theories, as you mentioned could it remove the way for the vaccine? that is possible. i think there is other i
and an fda issued a warning against using this to treat covid-19.barrassing admission. they have not reviewed data of the covid-19 patients to treat or to prevent covid-19. joining me now is a man's testimony, president and chief medical officer of the frontline covid critical care alliance, dr. pierre kory this is wildly rep and this wasn't of heidrick hydric clocks of corn. but the fda has to come out against therapeutics because otherwise the directive for the vaccine wouldn't make as much...
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71
Mar 25, 2021
03/21
by
CSPAN3
tv
eye 71
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fda. the fda will do its things and then make a recommendation and we will be ready from an operations perspective to roll out the vaccines and make sure that kids are get vaccinated. so i don't know if i have a crystal ball here, chelsea, but i can tell you that we'll be ready as the science evolves, as the data comes out, and as the fda and the cdc do the -- do what they usually do, what they are great out, to be able to roll out the vaccines the same with j&j. we waited. we got the -- as the fda and the cdc were evaluating the results of the studies, we were getting ready to roll out the vaccine and we were able to roll it out literally the following day after it was approved to start shipping to to states, tribes, and territories. i think the most important part here is to make sure that everybody is getting vaccinated when their turn is coming. we are creating so many opportunities for people to get vaccinated, whether it's at federal retail pharmacies, whether it's at community vacci
fda. the fda will do its things and then make a recommendation and we will be ready from an operations perspective to roll out the vaccines and make sure that kids are get vaccinated. so i don't know if i have a crystal ball here, chelsea, but i can tell you that we'll be ready as the science evolves, as the data comes out, and as the fda and the cdc do the -- do what they usually do, what they are great out, to be able to roll out the vaccines the same with j&j. we waited. we got the -- as...
60
60
Mar 22, 2021
03/21
by
KGO
tv
eye 60
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authorization, fda approval that is gold standard. >> they will now apply for fda approval. >> happening today, contra costa county quill honor the lives lost since the first known death there. since march 22nd of last year, more than 730 county residents died. the hope and feeling virtual event will honor their memories and prot moat community healing. there will be live music and broadcast from contra costa regional medical center and starting at 8 p.m. >> the biden administration's message is changing. more than 15,000 unaccompanied miners are now in u.s. custody after crossing over from mexico. they are struggling to find safe housing for many of them. 5,000 kids and teens are in u.s. border controlled kuss different. over 800 is more than ten days. the biden add plane station says they inherited a broken system. >> the entire system under united states law that has been in place throughout administrations of both parties was dis whatled in its entirety by the trump administration. >> and recent days the administration warned migrant families that the border is closed and secure urgi
authorization, fda approval that is gold standard. >> they will now apply for fda approval. >> happening today, contra costa county quill honor the lives lost since the first known death there. since march 22nd of last year, more than 730 county residents died. the hope and feeling virtual event will honor their memories and prot moat community healing. there will be live music and broadcast from contra costa regional medical center and starting at 8 p.m. >> the biden...
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127
Mar 23, 2021
03/21
by
CNNW
tv
eye 127
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then the advisory committee will make a decision to the fda and the fda will decide. data as a represent of the federal government and he feels strongly that it's a good vaccine, that this was an unforced error, as he calls it, that astrazeneca should release all of the data right now instead of holding some of the data. it's going to be one of those things that causes people to be a little hezbollah at that particular time about this vaccine, which we don't need. >> are you concerned it's going to make people not only more hesitant to take this vaccine but other vaccines? we know vaccine hesitancy is a concern in the united states? >> yeah, it is. about a third of the population still has some vaccine hesitancy. i don't know if what's happening with astrazeneca will necessarily transit to hesitancy with other vaccines. i just don't know. we had these clot situations in europe being associated with astrazeneca that was subsequently found not to be the case from world health organization and the european medicine association. they're saying there is no relationship bet
then the advisory committee will make a decision to the fda and the fda will decide. data as a represent of the federal government and he feels strongly that it's a good vaccine, that this was an unforced error, as he calls it, that astrazeneca should release all of the data right now instead of holding some of the data. it's going to be one of those things that causes people to be a little hezbollah at that particular time about this vaccine, which we don't need. >> are you concerned...