FDA

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FDA Limits Authorized Use of Johnson & Johnson Vaccine

If they can, adults should get Moderna or Pfizer coronavirus shots, agency says

(Newser) - Referring to new data on blood clots, the Food and Drug Administration announced limits Thursday on who should and should not be administered Johnson & Johnson's coronavirus vaccine. Only adults unable to receive other vaccines instead, either because the products are inaccessible or they're not clinically appropriate, are...

Feds Are Preparing Plan to Ban Menthol Cigarettes
FDA Makes Big Move
to Curb Smoking
UPDATED
Apr 28, 2022 11:05 AM CDT

FDA Makes Big Move to Curb Smoking

Agency announces plan to ban menthol cigarettes

(Newser) - Update: The FDA on Thursday made one of its biggest moves in more than a decade to curb smoking by unveiling a plan to ban menthol cigarettes, reports the New York Times . Now comes a 60-day period for public comments, followed by any needed revisions. It could be at least...

The Mouse Infestation at FDA HQ Is Sort of Normal

It turns out mice, other critters are common around White Oak, but pandemic didn't help

(Newser) - It could happen in any office building from which staff made hasty, "temporary" departures at the start of the pandemic. One week rolled into the next, and the workers did not return, but all those snacks around their offices remained. Local rodents took notice, apparently, at the FDA's...

FDA Authorizes Second Booster for Ages 50 and Older

CDC will weigh in next on the extra COVID shots

(Newser) - Update: The FDA on Tuesday authorized a second booster shot for people ages 50 and older, reports the Washington Post . The Pfizer or Moderna shots won't be made available until the CDC weighs in, and the agency is expected to quickly back the extra booster for those whose first...

FDA Updates Baby Formula Warning After Second Death

Abbott's Similac, Similac Alimentum, EleCare from Mich. plant tied to deadly bacteria

(Newser) - Update: The Food and Drug Administration has updated its warning on infant formulas made at a Michigan plant after the death of another child. The FDA warned against using Similac PM 60/40 with lot code 27032K800 on the case and 27032K80 on the can, NPR reports. Manufacturer Abbott said in...

'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...

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