FDA solicits stakeholder input on the latest version of its software precertification program working model.
Federal Register notice: FDA posts a list of information collections that have been approved by the Office of Management and Budget.
Federal Register notice: FDA makes available a draft guidance entitled S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Questions and Answers...
FDA clears a B. Braun Medical 510(k) for its wireless second generation software for its Perfusor Space Syringe Pump.
CDER deputy director Douglas Throckmorton describes agency efforts to ease shortages of IV fluids, injectable opioid analgesics, and EpiPen.
Stakeholders suggest things to be considered in developing tissue agnostic therapies.
FDA lifts a clinical hold against Solid Biosciences Phase 1/2 clinical trial for its investigational microdystrophin gene transfer, SGT-001, for treat...
FDA clears an Arcuro Medical 510(k) for its SuperBall meniscus repair system.