New Drug Pathway Must Weigh Risk, Off-Label Use, FDA Hears

Law360, New York (February 4, 2013, 6:24 PM EST) -- A U.S. Food and Drug Administration panel Monday weighed competing visions of a proposed approval pathway for pharmaceuticals targeting unmet medical needs, with advocates for drugmakers, doctors and patients debating appropriate limits on off-label use and asking the agency how risky medications can be.

The hearing stemmed from a September recommendation by the President's Council of Advisors on Science and Technology that the FDA consider approving new therapies for serious and life-threatening illnesses based on relatively small clinical trials focusing on the sickest patients.

Andrew J....
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