New FDA advertising standards require drug marketers to ensure their direct-to-consumer advertisements major statement is presented in a clear, conspi...
Republican Sen. Ron Johnson orders FDA, HHS, and CDC to preserve all records relating to Covid-19 vaccines, saying they will be subpoenaed if they are...
CDER deputy director for regulatory programs Doug Throckmorton announces his retirement after 27 years at the agency.
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Federal Register notice: FDA makes available a draft guidance entitled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Prod...
Federal Register notice: FDA determines that GlaxoSmithKlines Jesduvroq (daprodustat) tablets were not withdrawn due to safety or effectiveness reason...
FDA asks members of its Digital Health Advisory Committee to spend two days discussing agency questions about its role in regulating generative artifi...
FDA sends Astellas Pharma a complete response letter on a supplemental NDA for Izervay (avacincaptad pegol intravitreal solution) seeking revised drug...
