MedPage Today on MSN

After recent leadership departures, is the FDA returning to form?

Experts clash over significance of agency's reversals on certain rare disease drugs ...
Healio

BLOG: Whither AzaSite? The Thea Dark Forest era

What is going on with AzaSite? It has been unavailable since late March. Thea has been completely unhelpful. Is it indifference? Incompetence? Perhaps it is the difference between running a small ...
FiercePharma

FDA dings Piramal API plant with Form 483 detailing problems tied to quality control, equipment cleaning and more

Piramal’s latest FDA reprimand comes after the company disclosed the receipt of a separate Form 483 at its API facility in Michigan last February. (hudiemm/iStock/Getty Images Plus) Roughly a year ...
RAPS

FDA drafts guidance on best practices for responding to inspection observations

The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.
JD Supra

FDA Issues New Guidance for Submitting Patent Information for Listing in the “Orange Book”

On Friday, June 12, 2026, the US Food and Drug Administration (FDA) released a draft guidance document, Forms FDA 3542a and FDA 3542: Questions ...
RAPS

FDA Proposes Changes to its Adverse Event Reporting Forms

The US Food and Drug Administration (FDA) is proposing several changes to its adverse event reporting forms, known within the industry as Forms 3500, 3500A and 3500B. FDA has three adverse event ...