GlaxoSmithKline asks the Supreme Court not to hear Tevas appeal of a federal appeals court decision in a case involving a so-called skinny label for t...
Two stakeholders raise questions about an FDA draft guidance on risk management plans to mitigate drug shortages.
Morton Grove Pharmaceuticals decides to close its business as part of a federal court-approved consent decree of permanent injunction over adulterated...
Woodfield Pharmaceutical president Adam P. Runsdorf pleads guilty to drug trafficking violations in the Eastern District of Texas federal court.
Harvard Medical School researchers suggest three ways FDA could improve its use of advisory committees.
FDA updates a Web page with enhancements to the CDRH electronic medical device reporting system.
The Medical Device Innovation Consortium launches an initiative to improve the accuracy of next-generation sequencing-based cancer diagnostics.
FDA commissioner Robert Califf discusses the agencys future actions in key priorities including evidence generation and accelerating progress against ...
