CDER Office of Prescription Drug Promotion cites Phoenix Molecular Imaging Center for promoting an investigational drug, 11C-acetate, as safe and effe...
FDA clears an eNeura 510(k) clearance for its single-pulse Transcranial Magnetic Stimulation device and expanded use in acute and preventive treatment...
Federal Register notice: FDA submits to OMB an information collection extension for Financial Disclosure by Clinical Investigators.
FDA clears a Safe Medical Design 510(k) for the Signal Catheter, a urinary catheter that is designed to reduce urethral trauma caused by premature bal...
FDA Review has posted the Federal Register notices for the week ending 3/1/2019.
FDA Review posts product approval summaries for the week ending 3/1/2019.
FDA issues a final guidance on Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and C...
Federal Register notice: FDA seeks comments on World Health Organization recommendations to impose international manufacturing and distributing restri...