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...
FDA releases an updated guidance on using animal-derived material in medical device manufacturing.
Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Viru...
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug applications and abbreviate...