Guidance For Industry - Assessment Of Abuse Potential Of Drugs - U.s. Department Of Health And Human Services - 2017 Page 10
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37Contains Nonbinding Recommendations
Question 4: Do the animal and human abuse-related data show that the drug has abuse
potential, and will it therefore be subject to control under the CSA?
The abuse potential assessment submitted by the applicant in the NDA should include full
protocols and primary data, as well as a statistical analysis of the data. The assessment should
also include a discussion regarding whether the data show that the drug has abuse potential,
proposed labeling for the DRUG ABUSE AND DEPENDENCE section and other relevant
sections, and a proposal for scheduling under the CSA, if appropriate (see Section III.E).
Following the CSS review of the information submitted in the NDA, CSS determines whether
the drug has abuse potential, suggests appropriate labeling, and drafts a CSA scheduling
recommendation.
B. When Abuse-Related Studies Should Be Conducted
Sponsors are encouraged to consult with FDA throughout the drug development program
regarding the appropriate assessment of abuse potential. In determining whether any specific
abuse-related study should be conducted, a sponsor may submit abuse-related questions or issues
to CDER’s Office of New Drugs (OND) review division, which will request a consultation from
CSS. Interaction with CSS through the review divisions can occur from the pre-IND stage
through the NDA review cycle.
In general, it is recommended that the specific abuse-related studies be conducted only after the
therapeutic dose range is determined. This is not usually known until phase 2 clinical studies are
completed, at the earliest. Knowledge of the therapeutic dose range should be used in
determining the appropriate doses in the specific abuse-related study. The order of the abuse-
related investigations generally starts with in vitro studies, followed by animal studies, and then
finally by a human abuse potential study, if appropriate. Physical dependence assessments
should be conducted first in animals, to provide information about behavioral effects that may
inform the design of a human physical dependence study. Assessment of human physical
dependence should not commence until information is available regarding the ability to safely
discontinue the test drug in study subjects, as discussed in Section V.E. Refer to Sections IV and
V for typical study design elements.
Sponsors are advised to discuss their planned abuse-related studies with CSS, or confirm that
such studies are not warranted, at the end of phase 2 to ensure the drug is adequately assessed for
abuse potential. Sponsors are also advised to summarize all abuse-related data for discussion
during a pre-NDA meeting with the OND review division, and to request CSS participation for
the meeting. The pre-NDA meeting is generally the appropriate time to confirm the planned
content for the abuse potential assessment and to describe the intended organization and data file
formats for the NDA submission. FDA will assess the abuse potential of a drug product and
determine the Agency’s recommendation for its scheduling under the CSA after all study
protocols and primary data submitted in the NDA have been reviewed.
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