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Panel to Vote on Ventricular Assist Device

05/14/2004

Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 6/8, fro...

Effective Date Confirmed on Microorganisms in Facilities

05/14/2004

Federal Register Direct final rule: FDA is confirming the effective date of 6/1, for the direct final rule that appeared in the 12...

OMB OKs Info on Postmarketing Studies

05/13/2004

Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry; Reports on the Status of Pos...

Nominations Sought for Advisory Committees

05/13/2004

Federal Register Notice: FDA is requesting nominations for voting and non-voting consumer representatives to serve on its advisory...

10 Advisory Panel Charters Renewed

05/13/2004

Federal Register Notice: The FDA commissioner is renewing the charter of the following advisory committees for an additional two y...

Anti-Infective Drugs Pediatric Subcommittee to Meet

05/13/2004

Federal Register Notice: FDA’s Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee will meet 6/9, from 8 a...

FDA OKs Pennfield Oil ANADA

05/13/2004

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an ANADA filed by Pennfield Oil Co...

Panel Meeting Canceled

05/10/2004

Federal Register Notice: FDA is canceling the 5/10 meeting of the Anti-Infective Drugs Advisory Committee reportedly because Brist...

FDA OKs Intervet NADA for Canine Diabetes

05/10/2004

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

FDA to Define Mode of Action for Combo Products

05/07/2004

Federal Register Proposed rule: FDA is proposing to amend its combination product regulations to define “mode of action̶...