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Tougher Accelerated Approval Standards Needed: Lancet

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Lancet Oncology calls for an end to a trend toward lowering the evidence threshold for accelerated drug approvals.

Guidance on the Index of Legally Marketed Unapproved Animal Drugs

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Federal Register Notice: FDA releases a Level 2 guidance: Small Entities Compliance Guide The Index of Legally Marketed Unapprove...

ICH Guidance on Analytical Sieving General Chapter

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Federal Register Notice: FDA releases an IHC guidance: Q4B Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH...

Date Added to Onglyza Review Period Notice

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Federal Register Notice: FDA adds a date to an 8/31 Federal Register notice announcing the determination of a regulatory review pe...

Workshop on Long-Term Nicotine Replacement Therapy

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Federal Register Notice: CDER plans a scientific workshop on the risks and benefits associated with the long- term use of nicotine...

FDA Issues ICH Capillary Electrophoresis Text Info

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FDA publishes an ICH guidance identifying pharmacopeial texts on capillary electrophoresis that can be used interchangeably.

FDA Advisory Panels Harder to Predict

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A Concept Capital analysis for TheStreet says FDA advisory committees are recommending that fewer new drugs and major new indicati...

Court Rejects Apotex Aricept Suit

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A North Carolina federal court rejects Apotex attempt to block exclusivity for another company for a generic form of Eisais Aricep...

Journal Article Shows Meridia Increases Cardiovascular Risk

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Two weeks before an advisory committee panel will review results from a safety study involving Abbott's weight-loss drug Meridia (...

Crying in the Wilderness Over Food Animal Antibiotics

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FDA Webview consulting editor John Scharmann says that despite rising public opposition to growth-promotion use of antibiotics in ...