Patients Get FDA's Ear, Opening Door To Relaxed Approvals

Law360, New York (July 30, 2013, 6:29 PM EDT) -- The U.S. Food and Drug Administration is poised to take patient perspectives on risks and benefits into account like never before, raising the possibility that regulators will apply a slightly relaxed standard for approving drugs and devices targeting the most serious and stubborn diseases, experts say.

The newest unprecedented opportunity for patient input emerged last week, when the FDA announced a public meeting about incorporating patient views on acceptable levels of risk and reward into the review process for medical devices.

Though patient advocates already get...
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