FDA Unveils Draft Plan For New Benefit-Risk Framework

Law360, New York (March 7, 2013, 8:32 PM EST) -- The U.S. Food and Drug Administration on Thursday released a draft five-year plan on developing a strong benefit-risk framework for reviewers to use during the drug and biologic review process, a plan required in the FDA's latest user fee agreements.

The draft plan fulfills one of the FDA's commitments in the prescription drug user fee agreement that was reached between the agency and industry last year.

According to the plan, the FDA will spend the rest of 2013 laying the groundwork for implementation. As part of...
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