FDA warns HomeoCare Laboratories about CGMP violations in its production of three misbranded homeopathic drugs.
FDA warns Dynavision that its D2 device is adulterated and misbranded and fails to conform to Quality System regulation requirements.
FDA issues a draft guidance on recommended nonclinical studies for microdose radiopharmaceutical diagnostic drugs.
Federal Register notice: FDA extends until 9/20 the comment period for an 8/14 Federal Register notice requesting feedback about abuse potential, actu...
Billy K. Groce (Knoxville, TN) pleads guilty to evading FDA veterinary drug regulations.
FDA accepts for review two Array BioPharma NDAs to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily f...
CDER director Janet Woodcock testifies before a 9/13 House Energy and Commerce Subcommittee on Health about Modernizing FDAs Regulation of Over-the-Co...
Federal Register notice: FDA makes available a guidance entitled Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical ...