Fresenius Kabi recalls (Class 1 device correction) its Ivenix Infusion System Large Volume Pump software due to multiple software and cybersecurity vu...
Federal Register notice: FDA announces an 11/21 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to review an AstraZeneca supplemental ...
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.
