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FDA’s Structured Benefit-Risk Assessment Framework To Come Online In FY 2014

 
• By Cathy Dombrowski

Drug reviews will include a benefit-risk summary assessment that states the rationale for regulatory action on a drug or biologic application and explains how differences of opinion among reviewers were resolved.

Drug manufacturers will begin seeing structured benefit-risk assessments of their products in the U.S. during fiscal 2014 as FDA integrates a new benefit-risk assessment framework into the review process for new molecular entity NDAs and original BLAs.

Use of the framework in reviewing efficacy supplements for new or expanded indications will follow in fiscal 2016

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