FDA posts a draft guidance entitled Regulatory Considerations for Prescription Drug Use-Related Software.
FDA posts a draft guidance entitled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigati...
FDA denies a 4/2020 Belcher Pharmaceuticals citizen petition that sought a requirement that drug makers of pre-12/2012-approved tacrolimus oral capsul...
FDA announces a 9/29 virtual public workshop entitled Patient-Reported Outcomes and Vision-Related Quality of Life Questionnaires.
FDA reportedly issues Novo Nordisk a Form FDA-483 that cites GMP deficiencies at its Clayton, NC, manufacturing plant, which is a key facility for mak...
FDA clears a B. Braun Medical 510(k) for its AQUAbase nX Reverse Osmosis System for providing high-quality water for dialysis patients.
FDA posts a draft guidance entitled Labeling for Biosimilar and Interchangeable Biosimilar Products.
FDA extends by 90 days its review of an Iovance Biotherapeutics BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy for treating pa...
