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Federal Register notice: FDA makes available a revised draft guidance entitled Rare Pediatric Disease Priority Review Vouchers.
FDA clears a Solio 510(k) for its Alfa Plus, intended for use in relieving chronic pain in addition to pain from trauma, sports injury and menstruatio...
FDA warns Scientific Solutions Global about CGMP and other violations in the production of finished drugs.
California reaches pay-for-delay settlements with four drug companies bringing $70 million to the state.
Public Citizen calls on the FTC to block the proposed merger of Pfizers Upjohn unit with Mylan.
Federal Register notice: FDA announces fiscal year 2020 rates for the establishment and re-inspection fees related to drug compounding outsourcing fac...
CDER says its NextGen Portal can receive pre-assigned NDA, IND, BLA, and DMF number requests starting 8/19.