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New Combination Product Guidelines Coming

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Microtest Laboratories president Steven Richter says FDA will issue new guidelines for combination products.

Waxman Criticized for Derailing Off-label Proposal

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The Coalition for Healthcare Communication says Congressman Henry Waxmans (D-CA) leak about an FDA proposal to clarify its policy ...

Centocor Files BLA for Psoriasis Therapy

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Centocor submits a BLA for ustekinumab, indicated for treating adult patients with chronic moderate to severe plaque psoriasis.

Limited Evidence for Phenylephrine Effectiveness: FDA

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FDA tells the Nonprescription Drugs Advisory Committee there is little evidence that OTC decongestants containing phenylephrine ac...

Citizen Group Wants Tobacco Bill Shelved

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A citizen advocacy group urges Congress not to burden FDA with tobacco regulatory authority.

Industry Urged to Support Doubling FDA Resources

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FDA Science Board members call on regulated industry to support a doubling in FDAs appropriated resources over the next five year...

Watson and Biovail Settle Generic Cardizem Case

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Watson Pharmaceuticals and Biovail Laboratories come to terms over an outstanding patent litigation involving a generic version of...

FDA Updates CGMP Requirements

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Federal Register final rule: FDA amends certain regulations to modernize CGMP requirements and harmonize requirements with foreign...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites AmeriFit Brands, GE Healthcare/General Electric, GlaxoSmithKline, and Sorenson M...

FDA Withdraws Outdated CGMP Proposal

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Federal Register Proposed rule: FDA withdraws a proposed rule amending certain CGMP requirements due to recent scientific and tech...