Federal Register notice: FDA announces an 11/16 public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fe...
Federal Register notice: Health and Human Services proposes to withdraw a final rule entitled Securing Updated and Necessary Statutory Evaluations Tim...
FDA announces the availability of a NextGen Portal for reporting the annual amount of listed human and animal drugs and human biological products that...
Zimmer Biomet recalls its Rosa One 3.1 Brain Application, a robotic platform that helps neurosurgeons with positioning medical instruments or implants...
FDA authorizes the emergency use of Pfizer-BioNTechs Covid-19 vaccine in children ages five through 11 years.
Federal Register notice: FDA announces a periodic listing of Emergency Use Authorizations for certain medical devices related to the Covid19 public he...
Federal Register notice: FDA posts a list of information collections that have been approved by OMB.
Federal Register notice: FDA issues a priority review voucher to Enzyvant Therapeutics in response to its approval of a qualified rare pediatric disea...