WORKSHOP A — Controlled Substances Bootcamp: An Introduction to Key Agencies, Regulation, and Scheduling
Baker & McKenzie LLP
Seth A. Mailhot
Husch Blackwell LLP (Washington, DC)
Get the background information you need to seamlessly follow and engage in the more in-depth discussions that will take place during the main conference.
- An introduction to the DEA and FDA: agency missions and organizational structures relative to controlled substance regulation
- Understanding the intersection between FDA and the DEA jurisdiction over controlled substances
- Defining a “controlled substance
- Understanding drug scheduling and the potential for abuse, safety, addictive potential and whether it has any legitimate medical applications
- Considering the process to obtain approval from the DEA for schedule I-V controlled substances
- Understanding abuse-deterrence, its current status, and its effect on the approval process
- Working effectively with the DEA and FDA
- Exploring the interplay between state licensing and federal regulations as they impact the discovery, development and marketing of controlled substances.
- Responding to DEA enforcement actions