FDA releases a report summarizing its 4/16 public workshop on clinical trial inclusion and exclusion.
Federal Register notice: FDA seeks comments on an information collection extension entitled Sun Protection Factor Labeling and Testing Requirements fo...
Federal Register notice: FDA makes available a draft guidance entitled Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and...
Federal Register notice: FDA requests nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device ...
Federal Register notice: FDA determines that Danocrine (danazol) Capsules, 50mg, 100mg, and 200mg, were not withdrawn from sale for reasons of safety ...
FDA classifies as Class 1 a bioMerieux recall of its Vitek 2 Gram Positive Antimicrobial Susceptibility Testing Cards due to false results for some st...
FDA approves a Biocodex SAS NDA for Diacomit (stiripentol) for treating seizures associated with Dravet syndrome in patients two years of age and olde...
FDA approves Roches cobas EGFR Mutation Test v2 as a companion diagnostic test for selecting patients suitable for AstraZenecas Iressa (gefitinib) in ...