Federal Register notice: FDA makes available a final guidance entitled Considerations for the Use of Real-World Data and Real-World Evidence to Suppor...
AdvaMed lists steps the federal government could take to improve patient access to at-home medical technologies.
FDA clears an Alcresta Therapeutics 510(k) for an expanded use for ReliZorb in children ages two to five years.
FDA clears a LivaNova 510(k) for its Essenz In-Line Blood Monitor that provides continuous measurement of essential blood parameters to perfusionists ...
Four members of Congress from Michigan call on FDA to do more to prevent infections from contaminated bone grafts.
FDA reminds industry and others about its policy on using the FDA name and logo in any materials without being specifically authorized by the agency t...
FDA publishes a white paper on the assessment approach to be used as part of CDERs Quality Management Maturity program.
FDA commissioner Robert Califf says much remains to be done to combat the changing opioid crisis in the U.S.
