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TMJ Implants Alleges 94 Errors in GAO Report

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Embattled device maker TMJ Implants says it found 94 false, misleading or erroneous statements in a GAO report in September about ...

FDA, EU Adopt Orphan Drug Application

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FDA and the European Union adopt a common application form sponsors can use to apply for orphan drug designation.

Company Sponsorship Biases Med Ed: Journal

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The British journal Nature says drug company funding is biasing continuing medical education programs.

FDA OKs Barrs Generic Combunox

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FDA approves a Barr Pharmaceuticals ANDA for a generic version of Forest Pharmaceuticals Combunox pain relief tablets.

Panel to Discuss Adolors Entereg

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Federal Register Notice: FDAs Gastrointestinal Drugs Advisory Committee will meet 1/23/08 to discuss Adolor Corp.s Entereg for acc...

Comments Extended on Sunscreen Monograph

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Federal Register Proposed rule: FDA extends to 12/26 the comment period for a proposed rule to amend the OTC sunscreen drug produc...

FDA Wants Another Phase 2 Study on Acne Scar Therapy

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Isolagen says it is modifying an ongoing Phase 3 trial for acne scar treatment Isolagen Therapy to address concerns FDA recently r...

FDA Clears 2 Merit Medical Products

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FDA clears Merit Medicals All Star hemostasis valve and Prelude marker tip introducer sheath.

CBER Updates Electronic Format Guidance

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CBER updates its guidance on providing lot release protocols in electronic format to remove references to outdated technology.

FDA Panel Backs Stronger Warning on Flu Drugs

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An FDA pediatric advisory committee votes to add stronger precautionary labeling to flu drugs Tamiflu (Roche) and Relenza (GlaxoSm...