Former FDA deputy commissioner Deborah M. Autor joins consulting group Healthcare Innovation Catalysts as chief executive officer.
FDA accepts for priority review an Adaptimmune Therapeutics BLA for afami-cel, an investigational engineered T-cell therapy for advanced synovial sarc...
Two stakeholders respond to FDAs request for comments on using digital health technologies to detect prediabetes and undiagnosed Type 2 diabetes.
FDA clears a GE HealthCare 510(k) for its Novii+ Wireless Patch, an antepartum and intrapartum maternal and fetal monitor that measures fetal heart ra...
FDA issues a final rule to amend the medical device GMP requirements of the Quality System regulation to harmonize and modernize the regulation with i...
FDA has completed a bioresearch monitoring inspection and mid-cycle review meeting for the Abeona Therapeutics BLA for pz-cel.
FDA releases the forms FDA-483 issued following inspections at four drug manufacturing facilities in three countries.
FDA publishes a final rule amending the medical device Quality System Regulation to harmonize it with an international standard used in other countrie...
