Federal Register notice: FDA makes available a revised draft guidance for industry entitled Charging for Investigational Drugs Under an IND: Questions...
Federal Register notice: FDA announces an 11/2-3 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting to discuss CDERs Quality ...
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Two stakeholders raise questions about an FDA draft guidance on risk management plans to mitigate drug shortages.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.
