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Pharmaceuticals CGMP Rule Draws Adverse Comments

04/04/2008

Federal Register Direct final rule: FDA is withdrawing a direct final rule in the 12/4/07 Federal Register that amended certain re...

Temple Bothered by Questions on Benefits of Lowering Cholesterol

04/03/2008

The fallout from Schering-Plough and Merck’s ENHANCE study results has the medical community questioning whether lowering ch...

FDA OKs Intervet Heifer Feed

03/31/2008

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an Intervet Inc. NADA for use of a...

FDA Approves IVX Animal Health sNADA

03/31/2008

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an IVX Animal Health, Inc. supplem...

Panel to Discuss Visioncare PMA

03/24/2008

Federal Register Notice: FDA will hold a meeting of the Ophthalmic Devices Panel of the Medical Devices 4/24-25, from 8:30 a.m. to...

Guidance on Labeling Antihypertensive Drugs

03/13/2008

Federal Register Notice: FDA is making available a draft guidance for industry, Hypertension Indication: Drug Labeling for Cardiov...

Industry Rep. Selectors Sought for Pediatric Panel

02/27/2008

Federal Register Notice: FDA is requesting that any industry organizations interested in participating in the selection of a nonvo...

Panel on Pediatric Cancer Drug Development

02/27/2008

Federal Register Notice: FDA’s Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee will meet 4/16, fro...

FDA Cancels Meeting on Jerini NDA

02/04/2008

Federal Register Notice: FDA is canceling the 2/20 Pulmonary-Allergy Drugs Advisory Committee meeting scheduled to discuss a Jerin...

Industry Rep Sought for Blood Panel

02/01/2008

Federal Register Notice: FDA is requesting that any industry organizations interested in participating in the selection of a nonvo...