FDA Details Expectations For Approval Of New Painkillers

Law360, New York (February 6, 2014, 8:33 PM EST) -- The U.S. Food and Drug Administration on Wednesday described its current expectations for development and testing of painkillers, outlining key standards for a drug class whose sometimes addictive properties have led to tremendous controversy and litigation.

In its draft guidance, the FDA discussed how its clinical trial demands will vary greatly depending on the type of painkiller or analgesic that is being studied. For example, a reformulated version of a previously approved medicine may need only one additional trial to prove safety and effectiveness, regulators said.

On the other end of the spectrum, manufacturers who want to sell an entirely new...

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