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Farm Antibiotics: Time for FDA to Think Outside the Box

[ Price : $8.95]

Consulting editor John Scharmann receives an unsatisfactory response from CVM about its continued approval of growth-promotant ant...

FDA Extends Review of Novartis Tekturna NDA

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FDA extends by up to three months its review of a Novartis NDA for its blood pressure drug Tekturna to allow additional data to be...

FDA Proposes to Expand Access to Investigational Drugs

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Federal Register Proposed rule: FDA proposes to amend its regulations to improve access to investigational drugs for patients with...

FDA Rule on Charging Patients for Investigational Drugs

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Federal Register Proposed rule: FDA proposes to amend its regulations by clarifying the circumstances in which charging for an inv...

Animal Drug Regs Implement Manufacturing Changes

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Federal Register Final rule: FDA amends its animal drug regulations to implement the manufacturing changes provisions for suppleme...

Postmarket Surveillance Info Sent to OMB

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Federal Register Notice: FDAs proposed collection of information on postmarket surveillance has been submited to the Office of Man...

LA District, SoCRA Plan Workshop on Trial Regs

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Federal Register Notice: FDAs LA District and the Society of Clinical Research Associates plan a public workshop 2/7-8 in San Dieg...

Celgene Challenges Barr ANDA for Thalidomide

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Celgene Corp. says it will file a patent infringement suit against Barr Pharmaceuticals over its ANDA for a generic copy of Thalom...

FDA OKs Blood Screening Test for Chagas Disease

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FDA approves Orthos Ortho T. cruzi ELISA Test System the first test used for screening blood donors to detect a blood-borne paras...

Committees Asked to Consider Ketek MedGuide

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FDA asks two advisory committees whether additional provider education and a MedGuide are the best ways to deal with adverse event...