Federal Register notice: FDA seeks comments as it evaluates current thinking about the design of studies intended to generate data to support investig...
Federal Register notice: FDA submits to OMB for approval an information collection extension for Prescription Drug Marketing Act of 1987 Administrati...
FDA clears a protocol amendment to expand the Phase 1b/2a clinical trial of Cotingas COTI-2 to evaluate additional cancers as a combination therapy.
FDA releases the FDA-483 with three observations from an inspection at Pine Pharmaceuticals.
CDER director of nonprescription drug products director Theresa Michele says the agency has issued a guidance on maximal usage studies to help OTC dru...
FDA asks manufacturers of OTC teething aids containing benzocaine to pull them from the market or face regulatory action to force them out.
FDA issues a guidance on developing drugs with an indication of prophylaxis to inhalational anthrax in certain persons.
The Solicitor General tells the Supreme Court the government believes the court should hear Mercks appeal of a Fosmax failure-to-warn case.