06/16/2006
Federal Register Notice: FDA has determined the regulatory review period for Novartis Corp.’s Inspra (eplerenone) is 2,135 days fo...06/16/2006
Federal Register Notice: FDA has determined the regulatory review period for Amylin Pharmaceuticals’ Symlin is 4,620 days (pramlin...06/16/2006
Federal Register Notice: FDA is withdrawing approval of 65 NDAs and 52 ANDAs from multiple applicants. The holders of the applicat...06/09/2006
Federal Register Notice: FDA is making available a guidance, Marketed Unapproved Drugs — Compliance Policy Guide, that describes h...06/09/2006
Federal Register Notice: FDA’s collection of information entitled "Evaluation of Consumer-Friendly Formats for Brief Summary in Di...06/09/2006
Federal Register Notice: FDA intends to take enforcement action against unapproved drug products containing carbinoxamine and pers...06/09/2006
Federal Register Notice: FDA has determined the regulatory review period for Asta Medica’s Cetrotide is 2,103 days for extending a...06/08/2006
Federal Register Notice: FDA’s Minneapolis District, in cooperation with the Association of Clinical Research Professionals will h...