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Controlled Substances: FDA and DEA Regulation of Pharmaceuticals

June 2012

The Food and Drug Law Institute

"Controlled Substances: FDA and DEA Regulation of Pharmaceuticals" is a must-have Primer for stakeholders working with controlled substances. With the user-friendly, practical guidance, readers will be able to create a strategy for approval and marketing that meets the complicated requirements of the Controlled Substances Act and Federal Food, Drug, and Cosmetic Act. This Primer takes a start-to-finish look at the regulatory system behind controlled substances, explaining the regulatory maze of the CSA and FDCA. It also provides a comprehensive overview of the CSA.

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The team

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