FDA posts a final guidance entitled Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.
Ainos files a clinical hold response seeking to begin a Phase 2 trial of its low-dose oral interferon (IFN)-alpha formulation Veldona.
Federal Register notice: FDA announces a 3/21 advisory committee meeting to discuss a de novo marketing request by Balance Ophthalmics for its intraoc...
Insight Pharmaceuticals recalls two lots of its TING 1% Tolnaftate Athletes Foot Spray Antifungal Spray Liquid due to elevated benzene levels.
Federal Register notice: FDA revokes the Emergency Use Authorizations for two Covid-19 tests issued to Southern California Permanente Medical Group an...
Due to an earlier Nurse Assist, LLC product recall, Cardinal Health is recalling products supplied to it for use in Covidien and Cardinal Health brand...
Vertex Pharmaceuticals plans to file an NDA by mid-year and use a priority review voucher for its cystic fibrosis combination drug, once-daily vanzaca...
Congressman Mike Waltz (R-FL) asks FDA for clarification on the agencys telework policies which have minimized the operational standards for approving...
