FDA solicits comments on a report outlining a structure for a public/private partnership to establish and operate a repository of antimicrobial use da...
FDA approves an expanded indication for Mercks Ebola vaccine Ervebo (Ebola Zaire vaccine, live) to include its use in individuals 12 months of age and...
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Federal Register notice: FDA posts a draft guidance entitled PDUFA Waivers, Reductions, and Refunds for Fixed-Combinations and Single-Entity Versions ...
Federal Register notice: FDA makes available a draft guidance entitled Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrov...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...
