Assessment of Abuse Potential of Drugs - Guidance for Industry
Abstract:Assessment of Abuse Potential of Drugs - Guidance for Industry
Abuse-Deterrent Opioids (Evaluation and Labeling) - Guidance for Industry
With the intent to assist applicants who seek approval for a new drug, particularly to evaluate the abuse potential of the drug, and to assist sponsors of investigational new drugs, these FDA guidance seek to offer insight into key decision points such as recommended studies in assessing abuse potential, cases when abuse-related studies should be conducted, preparing the NDA submission, NDA review and product labeling related to abuse potential, and the drug scheduling process.
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