Search Results for: FDA

Implementation of Consistent Language as Outlined in FDA Draft Guidance on Drug Abuse and Dependence Labeling Will Support Drug Development, Labeling and Prescriber Decision-Making

By Jack Henningfield, Karen Gerlach, Judy Ashworth, Marion Coe, Sid Schnoll Once finalized, FDA Draft Guidance “Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format” will help ensure more consistent language across drug products about abuse, misuse, addiction, dependence, and tolerance. Our experts in the development... Read more »... Read More >

Assessing Abuse Potential of Cannabinoids: Lessons Learned from Past CNS-Active Drug Development

The confusing and conflicting legal status of cannabis and its active constituents can inhibit product development as companies encounter significant and unique barriers to approval and appropriate scheduling. In a complementary webinar, Jack Henningfield, Ph.D., and Daniel Wang described how the development and regulatory submission of other CNS-active drugs, including the development of the FDA-required abuse potential assessment, provide important precedents and models for cannabinoids.... Read More >