Food and Drug Administration

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FDA Wants FOI Request on Vaccine to Wait—for 55 Years

Experts want to see information used in approving Pfizer's product

(Newser) - The experts who have filed a Freedom of Information request to see government data on the Pfizer COVID-19 vaccine might have to hand the issue down to the next generation—at least—of scientists and professors. The Food and Drug Administration has asked a judge to not force the documents'...

In Rare Move, Ex-FDA Chief May Return to Post

Robert Califf ran the agency, which is handling COVID vaccines with an acting boss, under Obama

(Newser) - President Biden on Friday chose Dr. Robert Califf, a former Food and Drug Administration commissioner and prominent medical researcher, to again lead the powerful regulatory agency. Califf's nomination comes after months of concern that the agency near the center of the government's COVID-19 response has lacked a permanent...

Kids as Young as 5 May Get Shots Next Week

FDA backs Pfizer shots for children, with final details to emerge next week

(Newser) - The Food and Drug Administration on Friday paved the way for children ages 5 to 11 to get Pfizer's COVID-19 vaccine. The FDA cleared kid-size doses—just a third of the amount given to teens and adults—for emergency use, and up to 28 million more American children could...

$50 Hearing Aids Without a Prescription? That&#39;s the Goal
FDA Making a Big Shift
on Hearing Aids
in case you missed it
Oct 23, 2021 4:55 PM CDT

FDA Making a Big Shift on Hearing Aids

Plan would make them available over the counter at a cheaper price

(Newser) - Nearly five years after it was urged to make affordable hearing aids available over the counter, the FDA is taking a big step toward that goal. In a plan released Tuesday , the agency says it will create a new category of hearing aids that will be made available online and...

FDA to Study Possible Moderna Side Effect

Decision will delay approval for 12- to 17-year-olds

(Newser) - With several European nations rethinking their endorsements of giving the Moderna vaccine to young people, the FDA will study a potential side effect longer before deciding on approval. The issue is myocarditis, a rare inflammatory heart condition, the Wall Street Journal reports. Finland, Sweden, Denmark, and Norway have called for...

FDA Panel Endorses J&amp;J Booster Shot
FDA Panel Endorses
J&J Booster Shot
Oct 15, 2021 1:42 PM CDT

FDA Panel Endorses J&J Booster Shot

Advisers set no timeline but says shot should come at least 2 months after the first one

(Newser) - A panel of US health advisers endorsed booster doses of Johnson & Johnson's single-shot COVID-19 vaccine Friday, saying they should be offered at least two months after immunization. J&J has asked the Food and Drug Administration for flexibility with its booster, the AP reports, arguing that the extra...

A Big First for FDA on E-Cigarettes
A Big First for FDA
on E-Cigarettes
Oct 13, 2021 2:19 AM CDT

A Big First for FDA on E-Cigarettes

Agency authorizes one to stay on the market

(Newser) - For the first time, the Food and Drug Administration on Tuesday authorized an electronic cigarette, saying the vaping device from RJ Reynolds can help smokers cut back on conventional cigarettes. E-cigarettes have been sold in the US for more than a decade with minimal government oversight or research. Facing a...

FDA Has to Decide Soon on Future of E-Cigarettes
FDA Decisions
Near on
E-Cigarettes
Aug 23, 2021 7:55 PM CDT

FDA Decisions Near on E-Cigarettes

Agency has deadline next month for approving companies' product applications

(Newser) - E-cigarette manufacturers soon will learn whether they're out of business, still in the market but facing new government controls, or back in in a big way. The companies were given a choice last year: pull their vaping products or seek Food and Drug Administration approval for them. More than...

Pfizer Vaccine Will Now Be Marketed Under a New Name

After winning full FDA approval, company can now sell it as Comirnaty

(Newser) - It's a big development on the COVID vaccine front: The FDA on Monday gave full approval to the Pfizer shots, reports the AP . The vaccine had previously been granted an emergency-use waiver, and winning full approval—it's the first vaccine to do so—could have wide-ranging implications.
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There's Been a Date Shift for FDA's Full OK on Pfizer Vax

Labor Day was the initial target. Sources now say full approval could come as soon as Monday.

(Newser) - Earlier this month, the Food and Drug Administration signaled that it hoped to offer full approval for Pfizer-BioNTech's coronavirus vaccine by Labor Day, an unofficial deadline that now looks like it's been expedited. A senior federal official tells CNN that such an FDA OK is "imminent,"...

FDA Authorizes 3rd COVID Vaccine Dose for 3% of Adults

CDC to issue recommendation on the boosters for certain immunocompromised people

(Newser) - A third COVID-19 vaccine dose has been authorized for certain immunocompromised Americans. The FDA on Thursday amended the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow a third dose for "solid organ transplant recipients or those who are diagnosed with conditions that are considered to have...

FDA Speeds Up Plans to Help Immunocompromised

Agency said to be fast-tracking COVID booster shots for the most medically vulnerable

(Newser) - Conversations within the FDA, CDC, and NIH have begun regarding COVID-19 booster shots, with the Biden administration indicating plans will pick up steam early next month to get that plan going for the general population. "The agencies are engaged in a science-based, rigorous process to consider whether or when...

FDA Approval of Alzheimer's Drug to Be Reviewed

Agency chief fears damage to public confidence in process

(Newser) - The acting head of the Food and Drug Administration wants the agency's inspector general to conduct an independent review of the agency's approval of a new drug to treat Alzheimer's. The approval process, which one outside adviser had called a "sham" as he resigned, has been...

Pfizer Wants Approval for Third Shot

Company agrees effectiveness of its vaccine is fading as Delta variant surges

(Newser) - Seeing signs that the effectiveness of its vaccine is fading, Pfizer said Thursday it will ask for approval to distribute a third dose to help fight new coronavirus variants. The company plans to ask the Food and Drug Administration for emergency use authorization next month, CNN reports. Pfizer cited findings...

FDA Walks Back Broad Alzheimer's Drug Advice

After criticism, agency says label will limit candidates to those with mild symptoms

(Newser) - After being widely criticized for approving the use of a new drug to treat all Alzheimer's patients, despite only limited evidence that it works, the Food and Drug Administration has stepped back from that decision. The agency announced its new instructions Thursday that say Aduhelm is intended only for...

New Alzheimer's Drug Spurs Big Concerns, an Investigation

2 House committees launch inquiry into approval, cost of Biogen's Aduhelm

(Newser) - It was supposed to have been a "cause for celebration," but instead, it's become a "catastrophe in the making." That's Axios' recent take on Aduhelm , the costly new Alzheimer's drug that was approved by the Food and Drug Administration despite major reservations from...

Another Company to Ask FDA to Approve Alzheimer's Drug

Biogen just won approval for its treatment despite experts' dissent

(Newser) - Eli Lilly is nearly ready to take another shot at getting approval for a possible Alzheimer's drug. The drugmaker said Thursday that it plans to submit its potential treatment donanemab to the Food and Drug Administration later this year. The announcement comes a few weeks after the FDA approved...

Cost of Alzheimer's Drug Could Push Medicare to the Brink

Biogen product would nearly double program's medication budget, though it might not work

(Newser) - The Food and Drug Administration's approval of a new drug to treat Alzheimer's disease could have enormous implications not just for patients, but for Medicare—even pushing the program toward collapse. FDA approval historically has meant Medicare will cover the cost of the medication, but with Biogen's...

Alzheimer Drug 'Debacle' Continues With Yet Another Resignation

Aaron S. Kesselheim is 3rd FDA adviser to resign after agency approves Aduhelm

(Newser) - The "debacle" over an Alzheimer's drug recently approved by the Food and Drug Administration continues, or at least that's how the commotion is being described by a third adviser to the agency who's now quit over it. Mayo Clinic neurologist Dr. David Knopman and Washington University...

FDA Advisers Quit Over Alzheimer's Drug: 'Sham Process'

They're not happy the agency OK'd Biogen's Aduhelm against panel's recommendation

(Newser) - The week kicked off with controversy swirling around aducanumab, the drug being marketed by Biogen as Aduhelm to treat Alzheimer's disease. The drama continues, with two members of an advisory panel to the Food and Drug Administration stepping down over the agency's decision to OK the drug against...

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