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Why are some drugs scheduled under the Controlled Substances Act (CSA)? How does a company hoping to test a CSA-scheduled drug to determine its potential medical value get access to it? What processes do players in the drug manufacturing and distribution chain need to follow if an approved drug falls under CSA classification? How do state controlled substance requirements differ from those of the federal government? The pharmaceutical industry is increasingly facing these kinds of questions regarding drugs subject to dual FDA and Drug Enforcement Administration (DEA) jurisdiction. Our panel of experts on both FDA and DEA law will provide an overview of the CSA, explain the interaction between the FDA and DEA regarding drugs subject to NDA approval, and discuss DEA supply chain requirements for approved drugs, including opioids. We will also discuss issues surrounding cannabis-related medical research.  

Speakers:

Larry K. Houck, Director, Hyman, Phelps & McNamara, PC
Lynn W. Mehler, Partner, Hogan Lovells US LLP
Lee Rosebush, Partner, BakerHostetler

Summer Learning Webinar Series – Available on Demand

Drug Pricing for the Food and Drug Community
Organic Chemistry for the Food and Drug Community

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2018-07-18T13:48:30+00:00