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De Novo Authorization for Allay Nerve Cap

[ Price : $8.95]

FDA grants Tulavi Therapeutics a de novo marketing authorization for its Allay Nerve Cap, a surgical hydrogel designed to protect ...

Diversity Action Plans Information Collection

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection entitled Diversity Action Plans (DAPs) for Clinical Studi...

Guide on Pediatric Inflammatory Bowel Disease

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Pediatric Inflammatory Bowel Disease: Developing Drugs for ...

Mainz Seeks Breakthrough Status for Colon Cancer Test

[ Price : $8.95]

Mainz Biomed files an application requesting a breakthrough device designation for what it calls its non-invasive next-generation ...

Device Chemical Analysis for Biocompatibility

[ Price : $8.95]

FDA announces an 11/6 public workshop entitled Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Supp...

Diamyd Granted Fast Track for Diabetes

[ Price : $8.95]

FDA awards Diamyd Medical a Fast Track designation for Diamyd (rhGAD65/alum) for use in treating Type 1 diabetes in pediatric pati...

Spectralis Optical Coherence Tomography Module Cleared

[ Price : $8.95]

FDA clears a Heidelberg Engineering 510(k) for its Spectralis optical coherence tomography angiography (OCTA) Module with SHIFT te...

Phelan-McDermid Therapy Given Rare Disease Status

[ Price : $8.95]

FDA awards Neuren Pharmaceuticals a rare pediatric disease designation for its drug candidate NNZ-2591 and its use in treating Phe...

7 Observations in Leiters Health FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 with seven observations from an inspection at the Englewood, CO-based Leiters Health outsourcing fac...