Federal Register notice: FDA determines that Endos Fortesta (testosterone) gel was not withdrawn due to safety or effectiveness reasons.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.
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.
