FDA clears an Imeka 510(k) for its Advanced Neuro Diagnostic Imaging (ANDI) quantitative imaging software, which is intended to generate a report for ...
Federal Register notice: FDA announces a 10/18-19 public meeting entitled Mitigating Clinical Study Disruptions During Disasters and Public Health Eme...
Federal Register notice: FDA posts a draft guidance entitled PDUFA Waivers, Reductions, and Refunds for Fixed-Combinations and Single-Entity Versions ...
Federal Register notice: FDA makes available a draft guidance entitled Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrov...
A bipartisan group of 28 House members asks FDA about the potential for drug shortages if supply chain members cant meet the 11/27 deadline for Drug S...
FDA publishes a guidance explaining the process for requesting a waiver, exception, or exemption from provisions of the Drug Supply Chain Security Act...
Washington Legal Foundation says the 2nd Circuit Court of Appeals upheld the dismissal of a case against Forest Pharmaceuticals over its Lexapro, agre...
An FDA online paper describes CDER research into and clinical applications of bispecific antibodies.
