A New York Magazine investigative report says FDA is partly responsible for delays in getting sufficient monkeypox vaccine doses into the U.S.
FDA grants breakthrough device designation to the Abbott deep brain stimulation system for use in treatment-resistant depression.
FDA says state-licensed pharmacists may prescribe Paxlovid but not Lagevrio.
FDA gives 510(k) clearance to a VideaHealth algorithm that can help dentists identify dental caries on patient X-rays.
Two Covington & Burley attorneys review the history of court preemption decisions involving over-the-counter drug monograph products.
CDER Office of Pharmaceutical Quality deputy director Mahesh Ramanadham outlines advantages found in an agency self-audit comparing regulatory actions...
Federal Register notice: FDA withdraws the approval of Xellia Pharmaceuticals ANDA for bacitracin for injection after the company requested that it be...
Six stakeholders comment on an FDA draft guidance on the CDRH Voluntary Improvement Program for medical device manufacturers.