Guidance For Industry - Assessment Of Abuse Potential Of Drugs - U.s. Department Of Health And Human Services - 2017 Page 6
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37Contains Nonbinding Recommendations
• A discussion as to which studies we recommend be included in an abuse potential
assessment for a CNS-active drug in order to satisfy the requirements of 21 CFR
314.50(d)(5)(vii), with recommendations for the battery of relevant studies that may be
conducted in a logical sequence that builds on new data acquired during drug
development
• A discussion as to when to conduct the recommended abuse-related studies, and how to
appropriately design them
• General administrative recommendations for obtaining FDA advice, consistent with
st
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CDER’s 21
Century review policies
and draft guidance for industry, Formal Meetings
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Between the FDA and Sponsors or Applicants of PDUFA Products
• A discussion regarding the abuse-related components of a NDA, including a proposal
(with justification) addressing whether the drug product should be scheduled under the
CSA, and if so, a proposed schedule (see 21 CFR 314.50(d)(5)(vii)). A scheduling
proposal may request any of the following: to control a substance in a particular
schedule, to decontrol a substance, to transfer a substance to a new schedule, or to not
control the substance.
It is beyond the scope of this guidance to discuss the abuse assessment of anabolic steroids (all of
which are in Schedule III of the CSA unless subject to an exemption, see 21 U.S.C.
§§ 811(g)(3)(C), 812). This guidance also does not discuss the studies that should be conducted
to demonstrate that a given opioid formulation has abuse-deterrent properties because that is
addressed in a separate FDA guidance for industry, Abuse-Deterrent Opioids – Evaluation and
5
Labeling (2015).
Biological products that are evaluated by the Center for Drug Evaluation and
Research (CDER) are not discussed in this guidance, but are still evaluated for abuse potential
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based on the principles in Section III.A.
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Available at
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Available for notice and comment purposes at
We
update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs
guidance Web page at
5
Available at
We
update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs
guidance Web page at
6
Assessments of abuse for biological products evaluated by the Center for Biologics Evaluation and Research
(CBER) are not discussed in this guidance.
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