Federal Register notice: FDA issues a draft guidance entitled The Special 510(k) Program.
Federal Register notice: FDA issues an order to debar Richard M. Fleming for 10 years from providing services in any capacity to a person that has an ...
FDA warns N-Molecular about CGMP violations in its production of PET drugs.
FDA posts a guidance entitled Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.
FDA issues a guidance with recommendations for selection of appropriate package type terms and appropriate discard statements for some drug, biologic,...
Researchers suggest a change in FDA reporting requirements for exception from informed consent clinical trials to better describe issues involving con...
The Justice Department says Amerisource Bergen is paying $625 million to resolve three whistleblower suits claiming that it operated a cancer supporti...
FDA releases its latest batch of Warning Letters that include Datascope Corp. and Sofie Biosciences.