FDA Instructs Opioid-Drug Makers On Abuse Deterrents

Law360, New York (January 9, 2013, 9:09 PM EST) -- The U.S. Food and Drug Administration on Wednesday laid out how drugmakers can develop ways of making opioid painkillers more difficult to abuse, while acknowledging that the agency does not yet have good data on whether existing abuse deterrents are effective.

The new draft guidance from the FDA, which was required by Congress, instructs drugmakers on what sorts of studies to conduct to test abuse deterrents, how the agency will evaluate deterrents, and how they will be included on drug labeling.

“While prescription opioids are an...
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