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Guidance on Vascular and Neurovascular Embolization Devices

02/25/2004

Federal Register Notice: FDA is making available a draft guidance for industry and FDA staff entitled Class II Special Controls Gu...

Panel to Discuss Hepatitis B Treatment

02/25/2004

Federal Register Notice: FDA’s Blood Products Advisory will meet 3/18, from 8 a.m. to 5 p.m. and on 3/19, from 8 a.m. to 3 p...

Panel to Vote on Total Artificial Heart

02/25/2004

Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 3/17-18 ...

FDA Delays Requirements for Rx/Blood Distributors

02/23/2004

Federal Register Final rule: FDA is further delaying, until 12/1/06, the effective date of certain requirements of a 12/3/99 final...

Revised Guidance on Antimicrobial Residues in Food

02/19/2004

Federal Register Notice: FDA is making available a guidance for industry entitled Assessment of the Effects of Antimicrobial Drug ...

Info on Serious Disease Clinical Trial Databanks Sent to OMB

02/19/2004

Federal Register Notice: FDA’s proposed collection of information, “Information Program on Clinical Trials for Serious...

Comment Sought on Device Reporting Rule

02/19/2004

Federal Register Notice: FDA is seeking public comment on reporting requirements related to the medical devices current good manuf...

Pediatric Study Summaries Available for Nine Drugs

02/19/2004

Federal Register Notice: FDA is making available summaries of medical and clinical pharmacology reviews of pediatric studies submi...

Pediatric Onocology Subcommittee to Meet

02/19/2004

Federal Register Notice: FDA’s Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee will meet 3/17/04, ...

Panel to Discuss Influenza Vaccine Formulation

02/19/2004