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CDRH releases a draft guidance entitled Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Prema...[ Price : $8.95]
FDA commissioner Scott Gottlieb praises the growth of the agencys medical device Private Payor Program that aims to shorten the ti...[ Price : $8.95]
Federal Register notice: FDA seeks nominations for members to serve on CDRHs Technical Electronic Product Radiation Safety Standar...[ Price : $8.95]
FDA grants Pfizer a breakthrough therapy designation for its investigational oral Janus kinase 3 inhibitor PF-06651600 for treatin...[ Price : $8.95]
FDA clears a Captiva Spine 510(k) for its TirboLOX-L 3D-Printed Titanium Lumbar Cages.[ Price : $8.95]
FDA launches a Quik Review Program pilot to reduce the maximum time for a 510(k) product application decision.[ Price : $8.95]
FDA issues a guidance to give sponsors or applicants the recommended format and content for submission of physiologically based ph...[ Price : $8.95]
FDA announces a 12/7 public workshop on quantitation of AAV-based gene therapy products.