FDA issues a draft guidance on developing drugs to treat heart failure.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.
FDA says 11 Medtronic insulin pumps have potential cybersecurity risks and diabetes patients who are using them should switch to a safer pump.
EdjAnalytics develops a predictive model to support CDERs decision-making process to select manufacturing sites for inspection.
Vyaire Medical recalls its enFlow Fluid Warming System disposable cartridges due to the potential for aluminum to elute from the warmer into the fluid...