06/19/2006
Federal Register Notice: FDA is making available a draft guidance, The Review and Inspection of Premarket Approval Application Man...06/19/2006
Federal Register Notice: FDA has determined the regulatory review period for Takeda Pharmaceutical’s Rozerem is 2,224 days for ext...06/16/2006
Federal Register Notice: FDA is withdrawing approval of 65 NDAs and 52 ANDAs from multiple applicants. The holders of the applicat...06/16/2006
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...06/09/2006
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...