19 Jan 2017

FDA Finalizes Guidance on Assessing Abuse Potential of Drugs | RAPS

FDA Finalizes Guidance on Assessing Abuse Potential of Drugs 


Posted 18 January 2017 By Zachary Brennan

A guidance finalized on Wednesday, almost six years after it was first drafted, looks to help sponsors of investigational new drugs in evaluating whether their new drug product has abuse potential.

More specifically, the US Food and Drug Administration (FDA) says the 37-page guidance offers recommendations for assessing the abuse potential of central nervous system (CNS)-active new drugs and whether they produce euphoria (or other changes in mood), hallucinations, and effects consistent with CNS depressants or stimulants.- See more at:

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