FDA

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FDA Advisers Endorse Vaccines Starting at 6 Months

Age group is the only one without access to COVID vaccines in US

(Newser) - COVID-19 shots for US infants, toddlers, and preschoolers moved a step closer to reality on Wednesday. The Food and Drug Administration's vaccine advisers gave a thumbs-up to vaccines from Moderna and Pfizer for the littlest kids. The outside experts voted unanimously that the benefits of the shots outweigh any...

FDA Posts Analysis of Pfizer Shots for Kids Under 5

Says the kid-sized dose appears to be safe and effective

(Newser) - Update: The FDA on Sunday posted its analysis of Pfizer’s COVID-19 vaccine for children under age 5, announcing that the kid-sized doses do appear to be safe and effective. The agency posted a similar analysis of Moderna's vaccine for the youngest age group last week. Next up: Wednesday'...

FDA Chief Takes Heat Over Infant Formula Shortage

Whistleblower's warning apparently languished in a mailroom

(Newser) - House members of both parties pressed the head of the Food and Drug Administration on Wednesday about how the infant formula crisis could have gotten this bad. "Why did it take an onslaught of national media attention for the Biden administration to act with a sense of urgency required...

CDC Panel Backs Booster for Ages 5-11
CDC: Children
5-11 Should
Get a Booster
updated

CDC: Children 5-11 Should Get a Booster

Rise in coronavirus cases prompts advisers' decision

(Newser) - Update: This file has been updated throughout with the CDC's decision. Children ages 5 to 11 should get a booster dose of Pfizer's COVID-19 vaccine, the Centers for Disease Control announced Thursday. An advisory panel had made the recommendation earlier in the day. The move opens a third...

The Dental Dam Finally Has Some Competition

The FDA has OKed underwear to protect against STIs during oral sex

(Newser) - "Oral sex is not totally risk-free," Dr. Jeanne Marrazzo, an infectious diseases expert with the University of Alabama at Birmingham tells the New York Times , but a newly FDA-authorized pair of underwear—vanilla scented, no less—has the potential to make it safer. STIs such as herpes, gonorrhea,...

FDA Clears Way to Increase Formula Imports
Formula Plant
to Go Back Online

Formula Plant to Go Back Online

FDA clears way to increase imports, as well

(Newser) - Federal officials on Monday reached an agreement to allow baby formula maker Abbott to restart its largest domestic factory, though it will be two months or more before any new products ship from the site to alleviate the national shortage facing parents. Under the agreement, Abbott must work with outside...

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

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

'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...

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