To Control Or Be Controlled: Navigating The Abuse Potential Evaluation Of CNS-Active Drugs For EU And U.S. Submissions

Delve into the key considerations for delivering an integrated preclinical and clinical abuse potential drug development evaluation that meets EMA and FDA regulatory requirements.

Topics being covered:

• Determining if your CNS- active drug requires abuse potential evaluation
• They reasons for evaluating abuse potential and how scheduling impacts a marketed drug
• The required preclinical and clinical studies and the best timing for their conduct
• The key differences in evaluating abuse potential for EMA and FDA drug submissions
• Strategically planning for abuse potential evaluation and identifying when a waiver may be warranted for certain components