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Start Time Changed for Drug Safety Meeting

05/09/2005

Federal Register Notice: FDA is amending a 4/14 Federal Register notice of a meeting of the Drug Safety and Risk Management Adviso...

Panel to Discuss Nitromed’s Bidil

05/06/2005

Federal Register Notice: FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet 6/15-16, from 8 a.m. to 5 p.m. at...

Workshop on Biologics for Plasma Protein Disorders

05/06/2005

Federal Register Notice: FDA’s Office of Public Health and Science in will hold a public workshop 6/13-14 entitled “Bi...

Panel to Discuss Hemodialysis Therapies

05/06/2005

Federal Register Notice: FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will mee...

Guidance on Toxicity Scale for Vaccine Trials

05/02/2005

Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Toxicity Grading Scale for Healt...

Review Period Set for Geodon

04/29/2005

Federal Register Notice: FDA has determined the regulatory review period for Pfizer’s Geodon (ziprasidone hydrochloride) is ...

Latest FDA Warning Letters

04/26/2005

Today FDA posted its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following e...

FDA Corrects Withdrawal of Sotalol HCL ANDA

04/22/2005

Federal Register Notice: FDA is correcting a 3/4 Federal Register notice that announced the withdrawal of approval of 76 NDAs and ...

FDA, Orange County to Hold Educational Conference

04/22/2005

Federal Register Notice: FDA is co-sponsoring its eighth annual educational conference with the Orange County Regulatory Affairs D...

Guidance on Combination Product User Fees

04/21/2005

Federal Register Notice: FDA is making available a guidance for industry and FDA staff entitled Application User Fees for Combinat...