CDRH releases a draft guidance entitled Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De N...
FDA commissioner Scott Gottlieb praises the growth of the agencys medical device Private Payor Program that aims to shorten the time between FDA appro...
Federal Register notice: FDA seeks nominations for members to serve on CDRHs Technical Electronic Product Radiation Safety Standards Committee.
FDA grants Pfizer a breakthrough therapy designation for its investigational oral Janus kinase 3 inhibitor PF-06651600 for treating patients with alop...
FDA clears a Captiva Spine 510(k) for its TirboLOX-L 3D-Printed Titanium Lumbar Cages.
FDA launches a Quik Review Program pilot to reduce the maximum time for a 510(k) product application decision.
FDA issues a guidance to give sponsors or applicants the recommended format and content for submission of physiologically based pharmacokinetic analys...
FDA announces a 12/7 public workshop on quantitation of AAV-based gene therapy products.