Coverage

FDA

Every FDA story we’ve published, newest first — each one sourced to the primary record.

FDA

8 stories

FDA

FDA Sets a July 30 Panel on Replimune’s Melanoma Drug

Jul 17, 20265 min read

FDA

FDA Can Now Ask the Public for OTC Monograph Data

Jul 17, 20265 min read

Guidance

FDA Retires a 1995 Guidance on Topical Steroids

Jul 17, 20265 min read

Devices

MDUFA VI: The Draft Deal Is Out, With a Faster 510(k) Clock

Jul 16, 20266 min read

FDA

FDA Sets a September Hearing on Psychedelic Therapy

Jul 16, 20265 min read

FDA

FDA Would Let Distributed Manufacturers Register Once

Jul 16, 20266 min read

Guidance

FDA’s OTC Monograph Meetings Guidance Is Final

Jul 16, 20265 min read

FDA

FDA’s Psychedelics Guidance Is Final, After Three Years

Jul 15, 20265 min read