"Breakthrough product" designation would speed drugs to patients

04/24/2012 | Brookings Institution (Washington, D.C.)

Recently proposed Senate legislation to designate certain experimental drugs as "breakthrough products" would allow the FDA to streamline the approval process without compromising safety, write Mark B. McClellan, director of the Brookings Institution's Engelberg Center for Health Care Reform, and Ellen Sigal with Friends of Cancer Research. The designation would reduce the total time and cost to develop the most promising treatments and minimize the number of patients receiving placebo or a treatment known not to work well, they write.

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Brookings Institution (Washington, D.C.)

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