Guidance For Industry - Assessment Of Abuse Potential Of Drugs - U.s. Department Of Health And Human Services - 2017 Page 5
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37Contains Nonbinding Recommendations
II.
BACKGROUND
The assessment of the abuse potential of a drug product under development is generally
conducted as a component of its safety evaluation. In this guidance, the term “abuse-related”
will be used to designate nonclinical and clinical information that is related to the assessment of
abuse potential of a new drug.
As described in Sections III through VI, the results from a broad range of studies and other
sources of information contribute to the assessment of a new drug’s abuse potential. This
includes the results of studies investigating chemistry, pharmacology, pharmacokinetics, animal
and human behavior, abuse-related adverse events (AEs) in human studies, and reports of abuse
from various sources, such as law enforcement, poison control centers, hospital emergency
departments and medical examiners. All abuse-related study protocols and resultant data should
be compiled and cross-linked by the applicant to constitute the abuse potential assessment within
an NDA submission. The assessment should include a proposal for scheduling under the CSA.
(Under 21 CFR 314.50(d)(5)(vii), if the drug has a potential for abuse, a description and analysis
of studies or information related to abuse of the drug, including a proposal for scheduling under
the CSA, are required.) Following the Agency’s review, these data inform both the appropriate
labeling of the drug product and our recommendations for drug scheduling under the CSA. In
this guidance, this required section of the NDA submission is referred to as the “abuse potential
assessment.” If an applicant concludes that its new drug product does not warrant scheduling
under the CSA, the scheduling proposal in the NDA should state this position, and should
provide justification for this position based on relevant data in the NDA.
A. Scope of Guidance
Drug products that are addressed in this guidance include those that contain CNS-active new
molecular entities (NMEs) as well as those products that contain CNS-active substances that are
2
already controlled under the CSA.
Generic drug products seeking approval under section 505(j)
of the Federal Food, Drug & Cosmetic Act are not typically reassessed for abuse potential, and
are usually placed in the same schedule of the CSA as the innovator drug product. Drug products
that are determined to have abuse potential may contain substances that are chemically or
pharmacologically similar to other controlled substances, or they may have novel chemical
structures and/or mechanisms of action in the brain.
This guidance provides the following:
• Definitions of drug abuse, abuse potential, and other related terminology
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The complete list of all scheduled substances can be found in
21 CFR
1308, which is updated following
publication in the Federal Register (FR) of a drug scheduling action by the Drug Enforcement Administration.
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