Amphetamine to Zolpidem: Navigating the ABCs of Early Phase CNS Drug and Cannabinoid Development

CNS drug development continues to evolve with changing regulations, particularly in light of prescription drug abuse and risk/benefit optimization.  The uncertainty with regulations around emerging therapeutics, including cannabinoids, adds to the confusion. Navigating a successful regulatory and commercial pathway for CNS drugs can pose challenges and delays when requirements are not met. In addition to NDA-enabling phase I studies, specialty studies may be required to further evaluate your risk/benefit profile and support a drug scheduling recommendation. This webinar will present a comprehensive overview of early phase CNS drug development and will help you navigate the regulatory requirements for successful submission.