Federal Register notice: FDA seeks comments on an information collection entitled Diversity Action Plans (DAPs) for Clinical Studies.
Federal Register notice: FDA makes available a draft guidance entitled Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment.
Mainz Biomed files an application requesting a breakthrough device designation for what it calls its non-invasive next-generation colorectal cancer te...
FDA announces an 11/6 public workshop entitled Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility...
FDA awards Diamyd Medical a Fast Track designation for Diamyd (rhGAD65/alum) for use in treating Type 1 diabetes in pediatric patients with Stage 1 or...
FDA clears a Heidelberg Engineering 510(k) for its Spectralis optical coherence tomography angiography (OCTA) Module with SHIFT technology, which is s...
FDA awards Neuren Pharmaceuticals a rare pediatric disease designation for its drug candidate NNZ-2591 and its use in treating Phelan-McDermid syndrom...
FDA releases the form FDA-483 with seven observations from an inspection at the Englewood, CO-based Leiters Health outsourcing facility.
