FDA Needs To Revamp Benefit-Risk Analysis, Drugmakers Say

Law360, New York (May 15, 2013, 7:56 PM EDT) -- The U.S. Food and Drug Administration’s new process for analyzing a drug’s benefits and risks needs to be drastically expanded, patient groups and drug companies have argued, saying if the agency did a benefit-risk calculation at every stage of the drug review process rather than as a final step, it could get more drugs to market, and faster.

In March, the FDA released a draft plan for implementing a new benefit-risk assessment and incorporating more patient perspective in the drug review process, and invited stakeholder comments...
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