Two stakeholders request changes to an FDA draft guidance on predetermined change control plans for medical devices.
Federal Register notice: FDA revokes the Emergency Use Authorizations issued to Cue Health for the Cue Covid19 Test, and Cue Covid19 Home/OTC Test.
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug sponsors.
FDA announces approved labeling changes for Sandoz fludarabine phosphate injection under the Oncology Center of Excellences Project Renewal.
FDA clears an Ultromics 510(k) for the EchoGo Amyloidosis for detecting cardiac amyloidosis.
Sage says it is ending dalzanemdor development in Huntingtons disease cognitive impairment following Phase 2 DIMENSION results that did not meet prima...
FDA warns the Colgate-Palmolive Toms of Maine unit about CGMP violations in its manufacturing of finished drugs.
Federal Register notice: FDA makes available a draft guidance entitled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Prod...
