FDA approves an Abiomed IDE to start an early feasibility study with a first-in-human trial of the 9 French Impella Expandable Cardiac Power heart pum...
Federal Register notice: FDA announces a 7/23 virtual public meeting on Reauthorization of the Prescription Drug User Fee Act.
FDA adds a new section to a clinical trial guidance that discusses 21 CFR Part 11 compliance for electronic systems used to generate electronic signat...
FDA posts a revised guidance entitled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coro...
FDA announces a 6/30 virtual meeting entitled Regulated Bioanalysis Workshop: Requirements and Expectations.
FDA accepts for review an Adamas Pharmaceuticals supplemental NDA for Gocovri (amantadine) as a treatment for off episodes in Parkinson's disease pati...
FDA clears a Transit Scientific 510(k) for its XO Score Percutaneous Transluminal Angioplasty Scoring Sheath platform for use in iliac, ilio-femoral, ...
Federal Register notice: FDA corrects a 5/27 notice on a guidance entitled Q3C (R8) Recommendations for the Permitted Daily Exposures for Three Solven...