FDA clears a Zimmer Biomet Holdings 510(k) for its Comprehensive Augmented Baseplate, which is intended to offer an alternative to bone grafting and e...
FDA issues Alkermes a Refusal to File letter on its NDA for New ALKS 5461 (buprenorphine and samidorphan), a once-daily, oral investigational medicine...
Federal Register Final Rule; technical amendment: FDA amends its good guidance practices regulation to inform the public on how to electronically subm...
Federal Register notice: FDA announces a 5/11 public workshop on medical gas regulation entitled Medical Gas Regulation: Workshop 3.
Vertice Pharma petitions FDA to revise and make more stringent bioequivalence requirements outlined in its Draft Guidance for Sucralfate Oral Suspensi...
FDA Review posts the Federal Register notices for the week ending 3/30/2018.
Federal Register notice: FDA announces a 5/24 public workshop on FY 2018 Generic Drug Regulatory Science Initiatives.
Federal Register notice: FDA announces a 4/24-25 joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting to ...