CDER director Patrizia Cavazzoni puts a positive spin on drug inspections, user fee goals, and enforcement and compliance activities, notwithstanding ...
FDA approves a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) injection, indicated for chronic weight management in adult and pe...
FDA says its Psychopharmacologic Drugs Advisory Committee will consider whether data from Acadia Pharmaceutical trials support an indication for the c...
Four Alston & Bird attorneys describe some of the major items in the PDUFA 7 reauthorization legislation that has bipartisan support in both the House...
Pfizer says it will stop enrolling standard risk patients in the EPIC-SR trial of its anti-Covid therapy Paxlovid and submit data to FDA in an NDA.
The Senate Health, Education, Labor and Pensions Committee passes the FDA Safety and Landmark Advancements (FDASLA) Act, which reauthorizes the agency...
Federal Register notice: FDA makes available a draft guidance for industry entitled Q9(R1) Quality Risk Management (QRM).
CDER director Patrizia Cavazzoni tells FDLI she is personally spearheading the Centers new rare disease efforts to speed and increase the development ...