Hogan Lovells Publications | Focus On Regulation | 25 January 2017

Just in time: FDA finalizes guidance on assessment of abuse potential of drugs

On 17 January 2017, just in time to evade the president's Regulatory Freeze Memorandum, the Food and Drug Administration (FDA) announced the availability of a final guidance entitled "Assessment of Abuse Potential of Drugs."

The guidance is intended to assist sponsors of investigational new drugs and applicants for approval of a new drug in evaluating whether their drug product has abuse potential. Specifically, FDA's guidance provides recommendations for assessing the abuse potential of central nervous system (CNS)-active new drugs. The guidance finalizes a draft guidance issued under the same name on 27 January 2010.

Read More: Just in time: FDA finalizes guidance on assessment of abuse potential of drugs

Download PDF Back To Listing