[ Price : $8.95]
FDA makes available a draft guidance entitled Drug Master Files.[ Price : $8.95]
Several lawmakers write FDA acting commissioner Ned Sharpless seeking more information about a recent Takeda Pharmaceuticals recal...[ Price : $8.95]
Bayer submits a supplemental NDA to extend the duration of use for its intrauterine device Mirena (levonorgestrel-releasing intrau...[ Price : $8.95]
FDA clears a Canon Medical Systems 510(k) for its Advanced Intelligent Clear-IQ Engine (AiCE) for use on the Aquilion Precision CT...[ Price : $8.95]
FDA posts a Form-483 from a July inspection at Ram Pharmas Idaho Falls, ID outsourcing facility.[ Price : $8.95]
FDA clears an Ortho Clinical Diagnostics 510(k) for the ORTHO Sera, a series of extended antigen phenotyping for use on the Ortho ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Drug Master Files.[ Price : $8.95]
Federal Register notice: FDA is publishing a list of information collections that have been recently approved by OMB.