The Latest Breaking News from FDA

Many ‘patient influencers’ offer medical advice without always revealing ties to pharmaceutical companies

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…

A federal judge has heard arguments in a lawsuit that poses a threat to the nationwide availability of a popular abortion medication

Tracy Droz Tragos’ documentary Plan C, now screening at SXSW, follows the ongoing fight to expand access to abortion medication.

U.S. District Judge Matthew Kacsmaryk said he would rule “as soon as possible” on the request for a preliminary injunction that would move mifepristone, a common abortion-inducing drug, off the market.