CDER OPDP lead project manager Jason Cober reviews in a Webinar the types of errors being seen in promotional submissions in eCTD format.
FDA warns Apothecus Pharmaceutical about CGMP violations in the production of combination products.
FDA warns Torrent Pharma about CGMP and other violations in its production of finished pharmaceuticals.
FDA warns Carolina Liquid Chemistries about manufacturing and distributing adulterated and misbranded reagents.
Federal Register notice: FDA announces a 12/5 public meeting entitled 2019 Public Meeting on CDER Standard Core Sets: Clinical Outcome Assessments and...
FDA issues a draft guidance with its thinking on enforcement discretion for animal drug compounding from bulk drug substances.
FDA releases its latest batch of Warning Letters that includes A.P. Deauville, Apothecus Pharmaceutical Corp., Carolina Liquid Chemistries, and Torren...
Reps. Cicilline and Nadler introduce legislation to strengthen FTC authority to win cases against drug companies that try to move patients to another ...