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FDA posts a revised guidance entitled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monito...[ Price : $8.95]
FDA announces a 6/30 virtual meeting entitled Regulated Bioanalysis Workshop: Requirements and Expectations.[ Price : $8.95]
FDA accepts for review an Adamas Pharmaceuticals supplemental NDA for Gocovri (amantadine) as a treatment for off episodes in Park...[ Price : $8.95]
FDA clears a Transit Scientific 510(k) for its XO Score Percutaneous Transluminal Angioplasty Scoring Sheath platform for use in i...[ Price : $8.95]
Federal Register notice: FDA corrects a 5/27 notice on a guidance entitled Q3C (R8) Recommendations for the Permitted Daily Exposu...[ Price : $8.95]
Federal Register notice: FDA announces the issuance and reissuance of Emergency Use Authorizations (EUAs) for certain medical devi...[ Price : $8.95]
FDA releases a PowerPoint slide show describing a new Web resource for labs performing Covid-19 tests that are authorized.[ Price : $8.95]
FDA grants Fitbit an emergency use authorization for its emergency ventilator, Fitbit Flow, for use during the Covid-19 public hea...