FDA clears a PerkinElmer 510(k) for its EuroImmun ANCA IFA and Europlus Granulocyte Mosaic assays and their use with the EuroPattern microscope.
Federal Register notice: FDA announces a 9/4 public hearing on its approach to enhancing competition and innovation in the biological products marketp...
FDA places a clinical hold on a Sarepta Therapeutics Phase 1/2 Duchenne muscular dystrophy micro-dystrophin gene therapy trial due to the presence of ...
FDA cautions South Koreas Ycellbio Medical Co. that it is marketing its Ycellbio kit in the U.S. without required premarket approval.
FDA cautions that no device can yet legally be considered an over-the-counter hearing aid within the definition in the FDA Reauthorization Act of 2017...
Federal Register notice: FDA announces a 9/12 Pharmacy Compounding Advisory Committee meeting.
Federal Register notice: FDA announces an 8/21 public workshop entitled Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Transla...
Four drug companies respond to an FDA request for input on developing guidance on assessing pH-dependent absorption and potential drug-drug interactio...