AbbVie told Stat that it had stopped airing the ad after the first half of the year and that it is complying with the FDA's investigation. So-called 'untitled letters' from the FDA for advertising ...

Two senators wrote to the FDA Friday about the Hims Super Bowl ad, which they said misleads patients about compounded weight ...

A group of Senators has warned the FDA about an ad expected to air during Sunday’s big game that they believe misleads ...

Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a U.S. drug ingredients plant tied to its longstanding subsidiary Genzyme.

In a searing letter penned to current FDA Commissioner Robert Califf, M.D., Polymeropoulos addresses the rejection Vanda received in September 2024, deeming the agency’s review process as ...

Following the president’s recent executive order dismantling diversity, equity, and inclusion policies, the main page for the ...

and certainly replying to 483's and Warning Letters. The course will go through what typically goes on during an FDA Inspection and will then cover how to prepare for, host and follow up to a ...

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration ...

In 2022, several consumer organisations and scientists petitioned the FDA to finally ban all remaining uses of Red 3. In November 2024, nearly two dozen Congress members sent a letter to the FDA ...

Breadcrumbs sold for months throughout the United States contain an undeclared allergen and are being recalled for safety reasons, the Food and Drug Administration announced on its website on Jan. 28.