Sen. Rick Scott (R-FL) introduces legislation that would require prescription drug labels in the U.S. to disclose where drugs and their active pharmac...
FDA discontinues the use of its Quality System Inspection Technique for medical device inspections and will instead conduct inspections using the proc...
Grail files the final module of its PMA for the companys multi-cancer early detection blood test.
FDA awards Biogen a breakthrough therapy designation for its experimental antibody litifilimab for treating cutaneous lupus erythematosus.
A group of Democratic senators ask HHS Office of Inspector General to clarify how it will oversee direct-to-consumer prescription drug sales tied to t...
FDA approves Tenpoint Therapeutics Yuvezzi as the only combination eye drop approved to treat presbyopia in adults.
FDA posts an updated guidance clarifying when clinical decision support software functions fall outside the definition of a regulated medical device.
An industry consultant says reduced FDA staffing levels and high turnover are extending regulatory timelines and forcing drug developers to invest mor...