FDA grants Polyganics a breakthrough device designation for its Liver and Pancreas Sealant Patch, which is designed to prevent fluid leakage after hep...
Federal Register notice correction: FDA corrects a 2/22 notice entitled Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meet...
FDA announces a 4/18 public workshop on Study Design Considerations for Devices including Digital Health Technologies for Sleep Disordered Breathing i...
Haynes and Boone petitions FDA to withdraw its draft guidance on generic mycophenolate mofetil oral suspension products.
FDA commissioner Scott Gottlieb tells Congress FDA is taking steps to further development of new types of flu vaccine.
Four senators introduce legislation to allow government officials to review patent claims even when Indian tribes claims sovereign immunity in what ma...
Vertax Biomedical says FDA improperly tainted an advisory committee meeting that led to agency approval of a BioMrieux 510(k).
A CDRH Webinar discusses ways to improve required annual reports submitted by manufacturers with a custom device exemption.