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by Lynn W. Mehler, Esq. and David M. Fox, Esq.
“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.
Topics addressed include substance scheduling, early drug development, pre-clinical and clinical abuse liability, submission of new drug applications, and more. This Primer also includes the following useful appendices: FDA 2010 draft guidance on the abuse potential of drugs; Single Convention on Narcotics of 1961; Convention on Psychotropic Substances of 1971; 2001 Denial of Petition to Reschedule Marijuana; CDER 2003 Manual on Policies & Procedures on “Consulting the Controlled Substance Staff on INDs and Protocols That Use Schedule I Controlled Substances and Drugs”; and CDER 2003 MPP on “Consulting the Controlled Substance Staff on Abuse Liability, Drug Dependence, Risk Management, and Drug Scheduling”.