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Review Period Set for Novartis

06/16/2006

Federal Register Notice: FDA has determined the regulatory review period for Novartis Corp.’s Inspra (eplerenone) is 2,135 days fo...

Review Period Set for Amylin’s Symlin

06/16/2006

Federal Register Notice: FDA has determined the regulatory review period for Amylin Pharmaceuticals’ Symlin is 4,620 days (pramlin...

FDA Withdraws 65 NDAs, 52 ANDAs

06/16/2006

Federal Register Notice: FDA is withdrawing approval of 65 NDAs and 52 ANDAs from multiple applicants. The holders of the applicat...

Guidance on Marketed Unapproved Drugs

06/09/2006

Federal Register Notice: FDA is making available a guidance, Marketed Unapproved Drugs — Compliance Policy Guide, that describes h...

OMB OKs Info on Consumer-friendly DTC Ads

06/09/2006

Federal Register Notice: FDA’s collection of information entitled "Evaluation of Consumer-Friendly Formats for Brief Summary in Di...

FDA Plans Enforcement on Carbinoxamine Products

06/09/2006

Federal Register Notice: FDA intends to take enforcement action against unapproved drug products containing carbinoxamine and pers...

Review Period Set for Cetrotide

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...

Minneapolis District Workshop on Clinical Trials

06/08/2006

Federal Register Notice: FDA’s Minneapolis District, in cooperation with the Association of Clinical Research Professionals will h...

FDA OKs Pfizer Equine Antiparasitics

06/08/2006

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of two supplemental new animal drug a...

Guidance on Virology Studies for Antivirals

06/05/2006

Federal Register Notice: FDA is making available a guidance for industry entitled Antiviral Product Development — Conducting and S...