Partners Lynn Mehler and David Fox Co-Author "Controlled Substances Act: FDA and DEA Regulation of Pharmaceuticals"
02 July 2012
FDA pharma/biotech partners Lynn Mehler and David Fox have co-authored a primer published by The Food and Drug Law Institute. Titled "Controlled Substances Act: FDA and DEA Regulation of Pharmaceuticals," the primer provides a comprehensive overview of the Controlled Substances Act (CSA) for pharmaceutical companies working with controlled substances. Topics addressed include the scheduling process, early drug development, development of preclinical and clinical abuse liability data, submission of the New Drug Application, and other CSA issues relevant to pharmaceutical companies.
As part of Hogan Lovells’ highly regarded FDA pharma/biotech group, Lynn and David lead the group’s practice in the field of drug products jointly regulated by the FDA and DEA.
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