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 ...
FDA approves Foundation Medicines FoundationOne CDx (F1CDx), a next generation sequencing-based in vitro diagnostic test that can detect genetic mutat...
FDA has released two user fee-related implementation plans one on resource capacity and the other on updated benefit-risk assessments.
Sunovion Pharmaceuticals files an NDA for APL-130277 (apomorphine) sublingual film, indicated for treating motor fluctuations (Off episodes) in patien...
FDAs Clinical Chemistry and Clinical Toxicology Devices Advisory Committee votes unanimously to recommend approval of Senseonics Holdings Eversense, a...
Federal Register notice: FDA announces a 5/22 joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advi...
A New York federal judge approves an FDA consent decree with dietary supplement manufacturer and wholesaler Riddhi USA.