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FDA Exploring Data-Driven Quality Reviews To Speed Generic Approvals

 
• By Joanne S. Eglovitch

FDA is seeking input from an advisory committee on the use of a more data-driven model the agency is exploring to standardize quality assessment in generic drug reviews. Agency officials explain that model could help expedite the review of generic drugs to meet review goals under GDUFA II. 

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FDA will be getting feedback from advisors next month on plans for a more data-driven model approach to guiding and expediting the quality aspects of generic drug reviews.

FDA's Pharmaceutical Science and Clinical Pharmacology Committee will meet Sept. 20 on the agency's plans to liberate a quality review...

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