Federal Register notice: FDA posts a draft guidance entitled PDUFA Waivers, Reductions, and Refunds for Fixed-Combinations and Single-Entity Versions ...
Federal Register notice: FDA makes available a draft guidance entitled Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrov...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.
Regeneron says it will respond to a recent FDA complete response letter on the companys BLA for a higher dose of Eylea (aflibercept) 8 mg to treat pat...
FDA warns Erlanger, KY-based RenatiLabs that it is illegally marketing human cell products that are manufactured with significant CGMP deviations.
