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...
Federal Register notice: FDA makes available a draft guidance entitled Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development.
Harvard University researchers who looked at FDAs use of advisory committees for new drugs say reforms in the process would improve transparency and a...
CDER Office of Infectious Diseases director John Farley answers healthcare provider questions about using Pfizers Paxlovid on authorized Covid-19 pati...
FDA permits marketing of a Fujirebio in vitro diagnostic test for Alzheimers disease.
Attorney Dara Levy predicts increased FDA enforcement involving so-called native advertising and other new promotional trends.
The International Council on Harmonization publishes its Model-Informed Drug Development Discussion Group roadmap for future guidelines.