FDA’s Risk-Benefit Plan May Drive More Drug Approvals

Law360, New York (March 13, 2013, 9:36 PM EDT) -- The Food and Drug Administration’s proposal for a new, more structured method for weighing the benefits and risks of a new drug could result in a more transparent and consistent approval process, more patient input and even more drug approvals if all goes as planned, experts say. 

The agency is looking to implement a new risk-benefit framework for new drugs and biologics, according to a draft of a five-year plan it released last week. Under the plan, the agency would create templates for reviewers to use as...
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