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...
Federal Register notice: FDA announces the issuance and reissuance of Emergency Use Authorizations (EUAs) for certain medical devices related to the C...
FDA releases a PowerPoint slide show describing a new Web resource for labs performing Covid-19 tests that are authorized.
FDA grants Fitbit an emergency use authorization for its emergency ventilator, Fitbit Flow, for use during the Covid-19 public health emergency.
FDA reminds laboratories to use transport media that are compatible with Covid-19 testing platforms and the processes used in their laboratory to proc...