MAR 28, 2018 9:00 AM PDT

Drug Development and Approval in the U.S.: Regulatory Challenges and Opportunities for Cannabis Therapies

Speaker
  • Attorney, Arent Fox LLP
    Biography
      Emily is member of the FDA practice group in Arent Fox LLP's Washington D.C. office. Arent Fox is a D.C.-based internationally recognized law firm that provides strategic counsel to clients that range from Fortune 500 corporations and start-ups, to trade associations and foreign governments. Emily focuses her practice on a variety of highly-regulated products including prescription and over-the-counter drugs, dietary supplements, foods, and cannabis. She routinely counsels clients on issues that affect the cannabis industry, such as licensing and permitting requirements, labeling and promotional review, good manufacturing and distribution practices, and supply chain management. Before joining Arent Fox, Emily worked at the U.S. Food and Drug Administration for nearly six years. She has followed the legalized cannabis industry since 2004, while during graduate school, she worked with a major county health department to implement the requirements of California's Medical Marijuana Identification Card Program (SB 420). Emily also speaks and writes regularly on current regulatory issues facing the cannabis industry. She earned a JD from American University, Washington College of Law, a Master of Public Policy from the University of Southern California, and BA from the University of Texas at Austin.

    Abstract

    Although more than half of U.S. states have legalized the use of medical marijuana, the U.S. Food and Drug Administration (FDA) has not yet recognized or approved the cannabis plant for therapeutic use.  This presentation will provide an overview of FDA’s framework for regulating drugs and explain the process of FDA review and approval of new drugs.   Special attention will be given to discussing the unique regulatory challenges and opportunities associated with developing cannabis therapies in the U.S., e.g., navigating the requirements of multiple federal regulatory agencies (FDA, NIDA, and DEA), developing botanical drug products, and FDA programs that grant expanded access to, and expedited review of, drugs intended to treat serious or rare diseases.
      
    Learning Objectives: 

    • Understand the requirements and process for obtaining FDA approval of new drugs, including phases of research and development, protocol development, approval of investigational new drug (IND) applications and new drug applications (NDAs) 
    • Understand unique regulatory challenges associated with developing cannabis therapeutics in the U.S. 

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