FDA warns Tender about CGMP and unapproved and misbranded new drug violations in its production of several over-the-counter drug products.
CBER says American Medical Aesthetics and Regenerative Medicine is marketing stem cell products without a valid BLA in place.
Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions made during January, February, and March.
FDA releases its latest batch of Warning Letters that includes Eosera and Tender Corp.
The U.S. House of Representatives passes an FDA spending bill that sets the agencys 2021 discretionary funding at $3.212 billion, an increase of $40.8...
Guided Therapeutics says it has submitted a clinical study protocol to FDA to support marketing of its LuViva Advanced Cervical Scan.
Israeli researchers say FDA has a robust vaccine approval and postmarketing surveillance system that worked well over the 20 years they studied.
CDER director Janet Woodcock defends the Centers use of integrated reviews from criticisms that they wont meet agency goals and may introduce new prob...