Federal Register notice: FDA sends to OMB an information collection extension for Information that should be included with Humanitarian Device Exempti...
Federal Register notice: FDA seeks comments on an information collection extension for biological and cell product deviation reporting.
FDA posts the FDA-483 issued following an inspection at the Dr. Reddys Unit 2 API manufacturing facility in Andhra Pradesh, India.
FDA clears a PhysIQ 510(k) for use of the companys algorithm to continuously determine respiration rate in ambulatory patients.
Washington Legal Foundation and PhRMA ask the 1st Circuit Court of Appeals to limit standing to sue in antitrust cases to those who have had direct fi...
HHS secretary Alex Azar says he and President Trump are working on a plan to allow the U.S. to import drugs from Canada.
Federal Register notice: FDA sets the medical device user fee rates and payment procedures for fiscal year 2020.
Federal Register notice: FDA makes available a revised draft guidance entitled Rare Pediatric Disease Priority Review Vouchers.