FDA warns Spains Casmara Cosmetics about CGMP and other violations in its production of finished pharmaceuticals.
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Genmabs Darzalex (daratumumab) is 1,939 da...
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Eli Lillys Portrazza (necitumumab) is 2,53...
Federal Register notice: FDA announces that its Office of Global Regulatory Operations and Policy, Office of Regulatory Affairs, and Office of Regulat...
Federal Register notice: FDA submits to OMB for approval an information collection extension for Export of Food and Drug Administration-Regulated Prod...
FDA updates standards for acceptance of data from medical device clinical investigations held outside the U.S. to help ensure data quality and integri...
The DC federal court rejects a Ferring request that it enforce summary judgment against FDA in a case involving new molecular entity exclusivity for t...
FDA approves an Osmotica Pharmaceutical NDA for Osmolex ER (amantadine extended release tablets) for treating Parkinsons disease and drug-induced extr...