FDA

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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'...

CDC Panel Backs Boosters, Especially for Ages 50 and Up

After one more step, shots could be made available to all adults this weekend

(Newser) - Update: This file has been updated to reflect the recommendation of CDC advisers. The US government on Friday moved to open up COVID-19 booster shots to all adults, expanding efforts to get ahead of rising coronavirus cases that experts fear could snowball into a winter surge as millions of Americans...

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...

First Country Approves Pill to Treat COVID
UK OKs the First COVID Pill
Nov 4, 2021 9:05 AM CDT

UK OKs the First COVID Pill

UK aims to deploy molnupiravir 'as soon as possible'

(Newser) - Britain granted conditional authorization on Thursday to the only pill shown to successfully treat COVID-19 so far. It is the first country to OK the treatment from drugmaker Merck, although it wasn't immediately clear how quickly the pill would be available, the AP reports. The pill was licensed for...

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...

FDA Panel Endorses COVID Shots for Kids

Vote was 17-0, with one abstention

(Newser) - The Biden administration has vaccines ready to roll for millions of children ages 5 to 11—and the plan cleared another hurdle Tuesday when a Food and Drug Administration panel endorsed the child-size doses of the Pfizer-BioNTech coronavirus vaccine. The panel of independent vaccine advisers voted 17-0 in favor of...

$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...

Booster Shots Are Expected to Start Going in Arms Today

CDC, Walensky gave final approval Thursday night

(Newser) - Update: An advisory panel unanimously recommended to the Centers for Disease Control and Prevention on Thursday that coronavirus vaccine booster shots be approved. Tens of millions of people would be eligible for the doses, which the FDA backed the day before, the Washington Post reports. (There's an explainer on...

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...

FDA Report Is Inconclusive on Johnson & Johnson Booster

Outside advisers are meeting this week to consider approval and interval

(Newser) - It's not clear yet whether people who received the one-shot Johnson & Johnson coronavirus vaccine will be cleared to get a booster shot or will be told to switch brands. A Food and Drug Administration staff report released Wednesday said that there's evidence the J&J booster strengthened...

FDA Issues New Guidelines on Salt
FDA Issues New
Guidelines on Salt
Oct 13, 2021 9:35 AM CDT

FDA Issues New Guidelines on Salt

The target is lower, but not yet at the recommended level

(Newser) - Food companies are coming under renewed pressure to use less salt after US regulators spelled out long-awaited guidelines aimed at reducing sodium levels in dozens of foods, from chain restaurant meals to chips, cereal, and baby food. The voluntary goals finalized Wednesday for 163 foods are intended to help lower...

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...

Pfizer Asks FDA to Authorize COVID Vaccine for Young Kids

Decision expected between Halloween and Thanksgiving

(Newser) - Pfizer and BioNTech formally requested that the FDA authorize emergency use of a coronavirus vaccine for more than 28 million US children aged 5 to 11 on Thursday, keeping in line with a plan to have the doses available by Thanksgiving . The FDA will now gather its vaccines advisory committee...

FDA Adds Its Approval to Booster Shots for Seniors

The third Pfizer dose ideally would be given six months after the second one

(Newser) - Update: Coronavirus booster shots for people 65 and older and adults otherwise vulnerable to severe illness received the Food and Drug Administration's approval on Wednesday. The agency decided that anyone in a high-risk situation, possibly because of their job, also should be able to get a Pfizer booster, the...

New Paper in Lancet: Most Don't Need Boosters

International review says they're not necessary for general population

(Newser) - A new international review of COVID cases reaches a clear recommendation: Hold off on booster shots for the general population. The new paper in the Lancet medical journal is authored by researchers from around the world, including two outgoing FDA scientists, reports the New York Times . They found no evidence...

Doctors, Pharmacists: Everyone Stop Using Ivermectin Now

AMA wants the prescriptions to stop

(Newser) - The American Medical Association has something to say about people taking ivermectin . And what they have to say, essentially, is knock it off, you’re going to get hurt. Ivermectin can be prescribed for humans for some problems—problems that have nothing to do with COVID. The CDC and FDA...

FDA Is Losing 2 of Its Vaccine Leaders

Head of the Office of Vaccines Research and Review and her deputy say they're out

(Newser) - Job openings have been at record levels this summer. Add two more openings to the tally. Two high-profile FDA vaccine regulators will depart the agency this fall, and the New York Times gives two points of context: One, that their exit could throw a wrench into the process of deciding...

Positive COVID Test Lacks One Key Element

As of now, people can't be told which variant they have

(Newser) - When someone learns they've tested positive for COVID, they might also discover that the news is surprisingly incomplete. As Insider reports, patients almost certainly will not learn which variant of the virus caught up with them. It's not because the lab can't figure it out—it's...

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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