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 accepts for priority review a Merck supplemental BLA seeking accelerated approval for Keytruda for treating adult and pediatric patients with recu...
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.
FDA says the Vyaire Medical recall of 2,150 units of its Tri-Flo suction system is Class 1.
HelloLife recalls four homeopathic drug products due to microbial contamination.
Federal Register notice: FDA releases a final guidance entitled Physiologically Based Pharmacokinetic Analyses Format and Content.