Latest U.S. Food and Drug Administration News

Over-the-counter hearing aids expected this fall in US

Aug. 16, 2022 19:21 PM EDT

WASHINGTON (AP) — Millions of Americans will be able to buy hearing aids without a prescription later this fall, under a long-awaited rule finalized Tuesday. The regulation creates a new class of hearing aids that don't require a medical exam, a prescription and other specialty...

CDC drops quarantine, distancing recommendations for COVID

Aug. 11, 2022 17:37 PM EDT

NEW YORK (AP) — The nation's top public health agency relaxed its COVID-19 guidelines Thursday, dropping the recommendation that Americans quarantine themselves if they come into close contact with an infected person. The Centers for Disease Control and Prevention also said people...

FDA: Take 3 home tests if exposed to COVID to boost accuracy

Aug. 11, 2022 16:05 PM EDT

WASHINGTON (AP) — If you were exposed to COVID-19, take three home tests instead of two to make sure you’re not infected, according to new U.S. recommendations released Thursday. Previously, the Food and Drug Administration had advised taking two rapid antigen tests over two or...

US will stretch monkeypox vaccine supply with smaller doses

Aug. 09, 2022 18:19 PM EDT

WASHINGTON (AP) — U.S. health officials on Tuesday authorized a plan to stretch the nation’s limited supply of monkeypox vaccine by giving people just one-fifth the usual dose, citing research suggesting that the reduced amount is about as effective. The so-called dose-sparing...

US rules out summer COVID boosters to focus on fall campaign

Jul. 29, 2022 16:13 PM EDT

WASHINGTON (AP) — U.S. regulators said Friday they are no longer considering authorizing a second COVID-19 booster shot for all adults under 50 this summer, focusing instead on revamped vaccines for the fall that will target the newest viral subvariants. Pfizer and Moderna expect...

NC woman pleads guilty to selling unapproved COVID-19 remedy

Jul. 28, 2022 13:33 PM EDT

CONCORD, N.H. (AP) — A North Carolina woman has pleaded guilty to charges that she sold unapproved drugs on her website that claimed to be remedies and treatments for COVID-19, the U.S. Department of Justice said. U.S. Attorney Jane E. Young said in a news release that Diana...

Altria's $13B investment in Juul e-cigarettes vaporizes

Jul. 28, 2022 11:20 AM EDT

WASHINGTON (AP) — Cigarette maker Altria's $13 billion investment in the troubled vaping company Juul has gone up in smoke — now worth less than 5% of its original value as U.S. regulators move to ban its e-cigarettes. Altria slashed the value of its Juul investment by more than...

FDA chief's long-promised opioid review faces skepticism

Jul. 27, 2022 11:13 AM EDT

WASHINGTON (AP) — As U.S. opioid deaths mounted in 2016, the incoming head of the Food and Drug Administration promised a “sweeping review” of prescription painkillers in hopes of reversing the worst overdose epidemic in American history. Dr. Robert Califf even personally...

How canine heart disease was tied to grain-free dog food

Jul. 23, 2022 13:08 PM EDT

In 2018, the U.S. Food and Drug Administration, acting on input from a group of veterinary researchers, began investigating whether the increasing popularity of grain-free dog foods had led to a sudden rise in a potentially fatal heart disease in dogs, dilated cardiomyopathy. Four...

FDA weighs oversight changes after formula, Juul troubles

Jul. 19, 2022 20:08 PM EDT

WASHINGTON (AP) — The head of the Food and Drug Administration has asked for a review of the agency's food and tobacco programs following months of criticism over their handling of the baby formula shortage and e-cigarette reviews. Tuesday's announcement comes as FDA Commissioner...