[ Price : $8.95]
Federal Register notice: FDA announces an 11/21 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to review an Astra...[ Price : $8.95]
Federal Register notice: FDA announces that a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting will review a Le...[ Price : $8.95]
FDA publishes a guidance with questions and answers on using electronic systems, records, and signatures in clinical investigation...[ Price : $8.95]
FDA releases the form FDA-483 with 13 observations from an inspection at the Exton, PA-based ProRx drug outsourcing facility.[ Price : $8.95]
FDA approves Fresenius Kabi and Formycons biosimilar Otulfi (ustekinumab-aauz), a copy of Johnson & Johnsons referenced Stelara.[ Price : $8.95]
Sen Bill Cassidy asks FDA to respond to questions about its decades-long failure to give Orange Book patent listing clarity to dru...[ Price : $8.95]
FDA warns East Rutherford, NJ-based Diamond Chemical about CGMP violations in the production of finished drugs.[ Price : $8.95]
FDA begins implementing a new model for FDA inspections as part of an agency-wide reorganization that was brought on by the 2022 i...