The Latest Breaking News from FDA

The Centres for Disease Control and Prevention has identified a rare strain of Pseudomonas aeruginosa in 68 patients across 16 states in the US due to contaminated eyedrops

Manila (AFP) - Philippine vlogger Rosanel Demasudlay holds a heart-shaped "virginity soap" bar in front of the camera and assures her hundreds of YouTube followers it can be safely used to "tighten" their vaginas.

In the wake of a joint investigation by KHN and CBS News into a dental appliance that multiple lawsuits allege caused grievous harm to patients, the FDA has begun looking into the product, the Anterior Growth Guidance Appliance, or AGGA, according to a former agency official.

U.S. health advisersare backing the continued use of Pfizer’s COVID-19 pill Paxlovid, saying it remains an important option for adults at high risk of severe illness

A federal judge is poised to restrict mifepristone – even though the drug has been safely and effectively used in the US for more than 20 years

"This type of activity would fundamentally de-stabilize the FDA regulatory system," a legal expert said.

WASHINGTON — A federal district judge heard oral arguments Wednesday in a controversial case that could decide the fate of the Food and Drug Administration’s approval of the abortion drug mifepristone — a decision that would have broad ramifications nationwide.

The case examines whether the FDA erred in its approval of a drug commonly used for both abortions and miscarriage management.

Nature, last month (paywall): The US Food and Drug Administration (FDA) will soon require [based on new federal legislation] researchers and companies seeking approval for late-stage clinical trials to submit a plan for ensuring diversity among trial participants…. The diversity requirement arrives in the wake of a 2022 report from…