Federal Register notice: FDA is releases a draft guidance entitled Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.
Federal Register notice: FDA posts a draft guidance entitled Content of Human Factors Information in Medical Device Marketing Submissions.
Federal Register proposed rule: FDA proposes to amend its regulations on INDs to exempt certain clinical investigations of lawfully marketed foods for...
Federal Register proposed rule: FDA proposes to replace its current annual reporting requirement for INDs with a new requirement: the annual FDA devel...
Remel recalls Thermo Scientific Gram Negative IVD AST Sensititre Plates due to the risk of potential false susceptible results for Proteae Tribe.
Janssen Pharmaceutical files a BLA for talquetamab for treating patients with relapsed or refractory multiple myeloma.
FDA grants Roche 510(k) clearance for its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181) Alzheimers Disease...
FDA seeks feedback on a discussion paper entitled Distributed Manufacturing and Point-of-Care Manufacturing of Drugs.
