FDA clears a VideaHealth 510(k) for its Videa Caries Assist, an artificial intelligence-powered dental caries (cavity) detection algorithm.
FDA limits the emergency use authorization of Janssens Covid-19 vaccine to certain individuals 18 years of age and older due to the risk of thrombosis...
Eleven CDER staffers say a Center self-audit of continuous manufacturing regulatory submissions verifies the benefits the agency has seen in such tech...
FDA approves a new indication for Daiichi Sankyos Enhertu for some breast cancer patients.
FDA-sponsored research demonstrates that patients who switch between generic levothyroxine products maintain the same level of thyroid function as pat...
FDA releases the FDA-483 with 15 observations issued following an inspection at the Edmond, OK-based Qualgen outsourcing facility.
Attorney Bradley Thompson uses data analysis to determine medical device inspection observations that more frequently are associated with Warning Lett...
Federal Register notice: FDA announces its renewal of the Anesthetic and Analgesic Drug Products Advisory Committee for an additional two years beyond...