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FDA Prohibits Extralabel Use of Flu Drugs In Poultry

03/22/2006

Federal Register Final rule: FDA is issuing an order prohibiting the extralabel use of anti-influenza adamantane and neuraminidase...

List of Approved PMAs Posted

03/17/2006

Federal Register Notice: FDA is publishing a list of premarket approval applications that have been approved and informing the pub...

Advisory Subcommittee Meeting Canceled

03/17/2006

Federal Register Notice: FDA is canceling the meeting of the Manufacturing Subcommittee of the Advisory Committee for Pharmaceutic...

Guidance on Drug/Biologic Combos

03/15/2006

Federal Register Notice: FDA is making available a guidance for industry entitled Nonclinical Safety Evaluation of Drug or Biologi...

FDA Determines Review Period for Ovidrel

03/15/2006

Federal Register Notice: FDA has determined the regulatory review period for Genzyme Corp.’s Ovidrel is 1,787 days for extending a...

Review Period Set for Crestor

03/15/2006

Federal Register Notice: FDA has determined the regulatory review period for AstraZeneca’s cholesterol-lowering drug Crestor (rosu...

Review Period Set for Relpax

03/15/2006

Federal Register Notice: FDA has determined the regulatory review period for Pfizer’s Relpax (eletriptan hydrobromide) is 2,829 da...

Review Period Set for Elan’s Prialt

03/15/2006

Federal Register Notice: FDA has determined the regulatory review period for Elan Pharmaceuticals’ Prialt (ziconotide) is 3,801 da...

FDA’s Science Board to Meet

03/15/2006

Federal Register Notice: FDA’s Science Board will meet 3/31, from 8 a.m. to 4 p.m. at FDA, Rm. 1066, 5630 Fishers Lane, Rockville,...

Guidance to Support Pandemic Influenza Vaccines

03/10/2006

Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Clinical Data Needed to Support ...