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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research

Q&A with FDA Podcast: A Step Forward in the Treatment of Opioid and Alcohol Dependence with Dr. Iilun Murphy and Dr. Marta Sokolowska

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Step Status
Educational Content ✘
Posttest ✘
Evaluation ✘
Starts On: Wed, 11/29/23: 12:00 AM EST
Ends On: Sat, 11/28/26: 11:45 PM EST
Type: Enduring Material
Credits: 0.5
Description: This enduring material activity focuses on the importance of the recent first generic approval to Vivitrol, a one-month extended-release injectable naltrexone that is used to help people recovering from opioid or alcohol dependence. The presenters will discuss the potential impact of this approval on public health along with the complexities involved with the approval.

This activity features educational content from the "Q&A with FDA" podcast series, produced by FDA's Division of Drug Information. This podcast series addresses some of the most frequently asked questions that we've received at the FDA.
Objectives:
  • Discuss the rise of the alcohol use crisis since the COVID-19 shutdown and naltrexone’s role in the treatment of alcohol and opioid abuse.
  • Identify challenges in the development of extended-released generic naltrexone products and FDA’s role to increase access to treatment and improve the quality and safety of drugs.
  • Describe how GDUFA has aided in the development of modern analytical methods and modeling tools to guide product development and bioequivalence study design.
  • Explain how FDA improves regulatory assessment efficiency and promotes a strong scientific foundation to develop novel approaches for product and bioequivalence testing.
Additional Information: Review the Activity Announcement for additional details: Announcement Form

Additional Resources:
Package Insert for Vivitrol

National Alcohol Abuse Statistics