FDA posts a final guidance entitled Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding ...
Federal Register notice: FDA releases a draft guidance entitled Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders U...
Jazz Pharmaceuticals sues FDA and seeks the reversal of a 5/1 approval of Avadel CNS Pharmaceuticals Lumryz, a sodium oxybate drug product citing Jazz...
Centers for Medicare & Medicaid Services (CMS) issues a proposed procedural notice outlining a new Medicare coverage pathway for breakthrough medical ...
FDA publishes a draft guidance on the formal dispute resolution and administrative hearing process for over-the-counter monograph drugs.
Federal Register notice: FDA announces the renewal of the Medical Imaging Drugs Advisory Committee for an additional two years beyond the charter expi...
Arrow International recalls its Arrow Endurance Extended Dwell Peripheral Catheter System due to the potential for catheter separation or leakage.
A Bloomberg newsletter covering India reports that Indian drug firms are sharing FDA inspection reports and their responses in an effort to improve in...
