FDA proposes to allow some biologic products to continue to reference drug master file information after transitioning to Public Health Service Act li...
FDA publishes an International Council on Harmonization guideline on validation of bioanalytical assays for chemical and biological drug quantificatio...
FDA posts videos explaining its Complex Innovative Trial Design pilot meeting program.
FDA issues a draft guidance on developing drugs to treat heart failure.
Federal Register notice: FDA makes available a draft guide entitled E19 Optimization of Safety Data Collection.
Federal Register notice: FDA makes available a final guidance entitled Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.
Federal Register notice: FDA seeks public comment on its Clinical Data Summary Report Pilot program as part of the agencys continuous assessment of th...
Kaiser Health News gives five takeaways from its review of a previously hidden FDA alternative summary medical device database that bypassed MAUDE.