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FDA OKs Valve Replacement Trial in Patients Under 60

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FDA approves an ATS Medical clinical study in which cardiac surgeons will implant the ATS 3f Aortic Bioprosthesis in patients unde...

Tobacco Advisory Committee Established

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Federal Register Final rule: FDA establishes the Tobacco Products Scientific Advisory Committee.

Consumer-level Pressure Mounts on Sharfstein Over Amalgam Rule

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An unprecedented consumer-level campaign against FDAs 8/4 mercury amalgams final rule erupts on the Internet, focusing public pres...

Ertaczo Ad Broadens Indication, Omits Risk Info: DDMAC

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DDMAC says that a 2008 journal ad for Ertaczo broadened the drugs indication, made unsubstantiated efficacy claims, and omitted im...

Mailer Creates New Intended Use for Nalfon

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DDMAC says that a Pedinol professional mailer for Nalfon suggests a new indication, omits and minimizes risk information, and make...

Orencia May be Used Earlier in Adult Arthritis Patients

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FDA approves a labeling change for BMS Orencia supporting its use in patients with moderate to severe rheumatoid arthritis of less...

FDA Calls Labopharms Trazodone Response Class 2 Resubmission

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FDA says that Labopharms response to the agencys complete response letter on trazodone is complete and is a Class 2 resubmission....

FDA Issues 2 Accredited Party Guidances

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FDA issues two guidances relating to accredited person Quality System and Good Manufacturing Practice inspections.

FDA Reiterates Stolen Levemir Concern

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FDA says that stolen lots of Novo Nordisk Levemir insulin may still be on the market and could be dangerous due to improper storag...

FDA Defines the Term Minor Use for Animal Drugs

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Federal Register Final rule: FDA further defines minor use in terms of the Minor Use and Minor Species Animal Health Act of 2004....