FDA

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'Unacceptable' Visitors at Family Dollar Site Lead to Closures, Recall

Rat infestation at Ark. distribution center forces 400-plus stores to close in South, product recall

(Newser) - Bad news if you're a regular at Family Dollar and you're in the South: Chances are, a location near you may be shuttered temporarily after a rat infestation at an Arkansas distribution warehouse. The Washington Post reports that 404 stores in six states—Alabama, Arkansas, Louisiana, Mississippi, Missouri,...

Senate Narrowly Confirms Biden's FDA Pick

6 Republicans backed Califf in 50-46 vote

(Newser) - The Senate narrowly confirmed President Biden’s pick to lead the Food and Drug Administration on Tuesday, pushing past a thicket of political controversies that threatened to derail what was initially expected to be an easy confirmation. The 50-46 vote means Dr. Robert Califf, a cardiologist and prominent medical researcher,...

FDA Gives Full Approval to Moderna Vaccine

Serious side effects have proved to be very rare

(Newser) - Moderna announced Monday that US health regulators have granted full approval to its COVID-19 vaccine, a shot that's been given to tens of millions of Americans since its emergency authorization over a year ago. The action by the Food and Drug Administration means the agency has completed the same...

FDA Deregulates This Salad Topping After 70 Years

Agency is revoking 'standard of identity' for French dressing, opening up ingredient possibilities

(Newser) - For nearly a quarter century, a trade group representing mayo, condiment, and salad dressing makers has been trying to get the Food and Drug Administration to back off a rule that holds one dressing in particular to what critics have said are overly strict standards. Now, it's "liberation"...

FDA: Fine to Get Booster After Just 5 Months

It also now recommends boosters for kids 12 to 15

(Newser) - The US is expanding COVID-19 boosters as it confronts the omicron surge, with the FDA allowing extra Pfizer shots for children as young as 12. Boosters already are recommended for everyone 16 and older, and federal regulators on Monday decided they're also warranted for 12- to 15-year-olds once enough...

With New Variant Comes Potential New Testing Issue

FDA warns that rapid antigen tests may not pick up on omicron that well

(Newser) - Not all news regarding the latest COVID-19 variant is gloomy, with very early signs pointing to less severe illness overall—meaning fewer hospitalizations and deaths—with omicron. When it comes to testing, however, the latest development doesn't bode well, per a warning issued by the Food and Drug Administration...

The Heart Pump Was Discontinued, but It&#39;s in Their Bodies
'Literally All You Can
Think About Is Death'
longform
Dec 26, 2021 5:20 PM CST

'Literally All You Can Think About Is Death'

ProPublica dives into problems faced by HVAD users

(Newser) - "Death. Literally all you can think about is death." It's what you might expect to hear from a patient before they were able to receive an implanted heart pump. But it's the after for an unfortunate group of patients who talked to ProPublica about their HeartWare...

FDA Drops Restriction on Abortion Pills

Decision will allow medication to be mailed, though some states are trying to block that

(Newser) - As political efforts to further restrict access to abortion reach across the nation—and to the US Supreme Court—the FDA has removed a barrier to obtaining abortion pills. The agency on Thursday made permanent a temporary lifting of a requirement that women pick up the medication to terminate early-stage...

FDA Approves Boosters for Some Teens

Specifically, those aged 16 and 17; CDC decision is pending

(Newser) - The US is expanding COVID-19 boosters, ruling that 16- and 17-year-olds can get a third dose of Pfizer’s vaccine, per the AP . The US and many other nations already were urging adults to get booster shots to pump up immunity that can wane months after vaccination, calls that intensified...

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...

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