[ Price : $8.95]
Federal Register notice: FDA is releases a draft guidance entitled Voluntary Malfunction Summary Reporting (VMSR) Program for Manu...[ Price : $8.95]
Federal Register notice: FDA posts a draft guidance entitled Content of Human Factors Information in Medical Device Marketing Subm...[ Price : $8.95]
Federal Register proposed rule: FDA proposes to amend its regulations on INDs to exempt certain clinical investigations of lawfull...[ Price : $8.95]
Federal Register proposed rule: FDA proposes to replace its current annual reporting requirement for INDs with a new requirement: ...[ Price : $8.95]
Remel recalls Thermo Scientific Gram Negative IVD AST Sensititre Plates due to the risk of potential false susceptible results for...[ Price : $8.95]
Janssen Pharmaceutical files a BLA for talquetamab for treating patients with relapsed or refractory multiple myeloma.[ Price : $8.95]
FDA grants Roche 510(k) clearance for its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181...[ Price : $8.95]
FDA seeks feedback on a discussion paper entitled Distributed Manufacturing and Point-of-Care Manufacturing of Drugs.