New Patient Rep Law Could Shake Up Drug Review Process

Law360, New York (August 16, 2012, 7:29 PM EDT) -- A new law that will get patients involved earlier in the U.S. Food and Drug Administration's drug and device review process has the potential, experts say, to shorten review times, get more drugs approved and encourage sponsors to shift their focus to patients' quality of life.

The law, a provision in the latest FDA user fee reauthorization, directs the FDA to get patient representatives involved in meetings with reviewers and drug sponsors. Pushed by patient advocacy groups, many of which want to get new treatments onto...
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