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Most FDA Reviewers Not Told to Meet PDUFA Review Goals, GAO Finds

Meeting specific review goals for drugs and biologics is generally not a criterion in FDA reviewers’ performance plans, according to a Government Accountability Office (GAO) report requested by Congress.

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FDA Warns Cold Sore Drugmaker as Review of OTC Skin Protectants Continues

The FDA has warned Quadex Pharmaceuticals that its cold sore treatment Viroxyn Professional was never approved as a new drug and does not conform to the formulation and labeling requirements for an OTC cold sore drug.

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Actavis Launches First Generics of GSK Parkinson’s Drug Requip XL

Actavis is launching generic versions of GlaxoSmithKline’s (GSK) Parkinson’s disease drug Requip XL and believes they are the first in the U.S.

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J&J Unit Tweaks Packaging Line After Imodium Recall

Johnson & Johnson (J&J) subsidiary McNeil Consumer Healthcare is modifying some of its packaging equipment after blister unit tears led to a recall of one lot, 53,892 packages, of diarrhea drug Imodium from wholesalers.

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