Assessment of Abuse Potential of Drugs - Guidance for Industry
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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.
Additionally, the guidance provide recommendations for applicants looking to submit NDAs (new drug applications) for prescription drug products with probable abuse potential and highlights FDA’s current thinking pertaining to studies that must be conducted to demonstrate that a given formulation has abuse-deterrent properties.
Related Training:
Understanding FDA Regulations and Role in Opioid Pain Management
3-hr Virtual Seminar: An Introduction to the FDA New Drug Approval Process
CNS-Active New Drugs
The guidance provide commendations for evaluating the abuse potential of new CNS (central nervous system)-active drugs. Drug products and drugs with abuse potential commonly contain substances that are active within the central nervous system, producing psychoactive effects like hallucinations and euphoria. A new drug product that contains drug substances that are CNS-active may need to undergo a complete assessment of its abuse potential, also subjecting it to control under the CSA (Controlled Substances Act).
FDA Focus Areas
The FDA is working across several areas to:
- Improve the assessment of abuse, particularly for abuse-deterrent formulations of opioids
- Facilitate development of new products to treat pain, that will offer improved safety and efficacy
- Promote the safe use of opioids through collaboration and partnership
For More Information
Abuse-Deterrent Opioids (Evaluation and Labeling) - Guidance for Industry
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