Attorney and data scientist Bradley Thompson blasts CDRH for its lengthy delays of up to 8,000 days in answering an average of 13 citizen petitions a ...
Federal Register notice: FDA provides notice that the courier address used for user fee payments has changed effective 10/6.
Federal Register notice: FDA announces that it revoked the Emergency Use Authorization issued to Becton, Dickinson for the BD Vacutainer Plus Citrate ...
Federal Register notice: FDA determines that Janssen Pharmaceuticals Ultram (tramadol hydrochloride) tablets, 50 mg, was not withdrawn from sale for s...
Moderna says it will start a Phase 3 trial of its investigational mRNA-1083 combination flu/Covid vaccine later this year.
Federal Register notice: FDA proposes to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal...
FDA warns Irving, TX-based Signature Biologics that it is illegally marketing its human umbilical cord product that is manufactured with CGMP deviatio...
FDA warns Fresenius Kabi about CGMP deviations in its Fenwal International unit in Maricao, Puerto Rico.
