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