FDA grants MiMedx Group a regenerative medicine advanced therapy designation for micronized amniotic tissue, AmnioFix Injectable, and its use in treat...
In an address to the Alliance for a Stronger FDA, CDRH director Jeff Shuren says the Centers real world evidence initiative is a top priority and will...
FDA releases the FDA-483 with five observations from a Pentec Health inspection.
FDA commissioner Scott Gottlieb describes the agencys innovative steps to better review and evaluate laboratory-developed tests.
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Haynes and Boone petitions FDA to withdraw its draft guidance on generic mycophenolate mofetil oral suspension products.