Researchers call on FDA to update guidances on endpoints for developing anti-infective drugs.
The Hill reports the Trump administration is proposing to lower some drug prices by ensuring that prices in this country are lower than comparable pri...
Eye on FDA notes a reduction in the number of drug-related advisory committee meetings this year and whether this can be seen as less transparency in ...
FDA principal deputy commissioner Lloyd Schiller says the agency is looking at changes to the Dietary Supplement Health and Education Act to enable it...
FDA places a Solid Biosciences Phase 1/2 trial of its SGT-001 Duchenne muscular dystrophy drug on clinical hold.
Federal Register notice: FDA sends to OMB an information collection extension for Product Jurisdiction: Assignment of Agency Component for Review of P...
FDA warns Mylan about significant deviations from CGMP requirements for active pharmaceutical ingredients at its Unit 8 in India.
FDA warns Indias Cadila Healthcare about CGMP violations in its manufacturing of finished pharmaceuticals.