Federal Register notice: FDA determines that Endos Fortesta (testosterone) gel was not withdrawn due to safety or effectiveness reasons.
FDA publishes a guidance with information on third-party review of 510(k)s and emergency use authorizations.
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.
Two stakeholders request changes to an FDA draft guidance on predetermined change control plans for medical devices.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.
