FDA publishes a guidance with recommendations on the information to be in a predetermined change control plan in a marketing submission for a device t...
FDA denies a Ferring Pharmaceuticals petition asking the agency to reconsider its earlier denial of a petition seeking restrictions on ANDAs citing Fi...
An FDA guidance asks manufacturers and applicants of drug products packed in infusion bags to collect and report data on nitrosamine impurities that c...
FDA clears a NeuroOne Medical Technologies 510(k) to market its OneRF Trigeminal Nerve Ablation System for use in procedures to create radiofrequency ...
FDA warns Lenoir City, TN-based Les Encres LLC about QS and MDR violations in its illegal work as a specification developer for adulterated and misbra...
FDA grants Altimmune a fast track designation for pemvidutide and its use for treating alcohol use disorder.
FDA posts a new draft guidance entitled Oncology Therapeutic Radiopharmaceuticals (RPTs): Dosage Optimization During Clinical Development.
Stealth BioTherapeutics resubmits its NDA for elamipretide for treating Barth syndrome.
