Guidance For Industry - Assessment Of Abuse Potential Of Drugs - U.s. Department Of Health And Human Services - 2017 Page 36

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Contains Nonbinding Recommendations
18
Each of these potential sources of abuse-related information has limitations,
which should be
delineated in an NDA submission if data from these sources are used. Not all of these data
sources are expected to be useful for all products. Post-marketing abuse data should be
presented within the context of prescription volume for the product(s) of interest. Where feasible
and appropriate, data on relevant comparator products should be included. Applicants should
also refer to CDER’s Guidance for Industry: Good Pharmacovigilance Practices and
19
Pharmacoepidemiologic Assessment (2005)
for recommended methods of assessing and
reporting safety through observational studies.
Although post-marketing data from US or foreign sources can provide important abuse-
related information, they are not a substitute for a thorough abuse potential assessment
conducted prior to submission of an NDA.
18
Secora, A.M. et al, “Measures to quantify the abuse of prescription opioids: a review of data sources and metrics”
Pharmacoepidemiology and Drug Safety 2014; 23: 1227- 1237.
19
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
33

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