FDA clears a Thornhill Research de novo marketing request for the ClearMate, intended to be used in an emergency room setting to help treat patients s...
Spectrum Pharmaceuticals withdraws a BLA for Rolontis (eflapegrastim), a treatment for chemotherapy-induced neutropenia in patients undergoing myelosu...
FDA releases a draft guidance expanding with questions and answers on an earlier guidance on a risk-based approach to clinical trial monitoring.
FDA publishes a guidance to help drug trial sponsors develop enrichment strategies that can be used to demonstrate drug and biological product effecti...
Federal Register notice: FDA seeks comments on an information collection extension for Inspection by Accredited Persons Program Under the Medical Devi...
Federal Register notice: FDA posts an updated Modifications to the List of Recognized Standards, Recognition List Number: 051.
Federal Register notice: FDA seeks comments on an information collection extension for Current Good Manufacturing Practice (CGMP) for Positron Emissio...
FDA issues a guidance on design of nonclinical studies to develop pharmaceuticals to treat patients with severely debilitating or life-threatening hem...