Federal Register notice: FDA announces that a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting will review a Lexicon Pharmaceutical...
FDA publishes a guidance with questions and answers on using electronic systems, records, and signatures in clinical investigations involving regulate...
FDA releases the form FDA-483 with 13 observations from an inspection at the Exton, PA-based ProRx drug outsourcing facility.
FDA approves Fresenius Kabi and Formycons biosimilar Otulfi (ustekinumab-aauz), a copy of Johnson & Johnsons referenced Stelara.
Sen Bill Cassidy asks FDA to respond to questions about its decades-long failure to give Orange Book patent listing clarity to drug/device combination...
FDA warns East Rutherford, NJ-based Diamond Chemical about CGMP violations in the production of finished drugs.
FDA begins implementing a new model for FDA inspections as part of an agency-wide reorganization that was brought on by the 2022 infant formula debacl...
The CDER Office of Prescription Drug Promotion says it will research how using an endorser to provide prescription drug information in a health-themed...
