FDA limits the emergency use authorization of Janssen’s Covid-19 vaccine to certain individuals 18 years of age and older due to the risk of thrombosis with thrombocytopenia syndrome.
Eleven CDER staffers say a Center self-audit of continuous manufacturing regulatory submissions verifies the benefits the agency has seen in such technologies.
FDA-sponsored research demonstrates that patients who switch between generic levothyroxine products maintain the same level of thyroid function as patients who use a single product.
Attorney Bradley Thompson uses data analysis to determine medical device inspection observations that more frequently are associated with Warning Letters.
Federal Register notice: FDA announces its renewal of the Anesthetic and Analgesic Drug Products Advisory Committee for an additional two years beyond the charter expiration date.
Harvard University researchers who looked at FDA’s use of advisory committees for new drugs say reforms in the process would improve transparency and accountability.