Federal Register notice: FDA issues an order debarring Brendon Gagne for five years from importing or offering for import any drug into the U.S.
Federal Register notice: FDA determines that TerSera Therapeutics Qmiiz (meloxicam) orally disintegrating tablets, 7.5 mg and 15 mg, were not withdraw...
Federal Register notice: FDA announces a 3/5 meeting of the advisory committee that will discuss strains to be included in next seasons flu vaccine.
FDA commissioner Robert Califf tells a George Washington University presentation on healthcare misinformation and disinformation that the country need...
FDA posts a six-item Form FDA-483 from a 9/2023 inspection at Sichuan Deebio Pharmaceutical Co. in Guanghan, Sichuan, China.
Three academic researchers say the FDA de novo medical device pathway has the potential to attract innovators who want to define new categories of dev...
CDER Office of Communications social scientist Alexandria Smith says the Center tests some communications intended for consumers or healthcare profess...
Federal Register notice: FDA seeks comments concerning recommendations by the World Health Organization to impose international manufacturing and dist...
