Appreciating the Nuances of the Approval Process for Controlled Substances
Lynn Mehler
Partner
Hogan Lovells (Washington, D.C.)
- Defining the term “controlled substance”?
- Reviewing the scheduling process for both approval as well as post- marketing approval with both the DEA and FDA
- Discussing the proper steps for companies who incorporate CBD’s into their products
- What clinical trial lab work is necessary to demonstrate to the proper agencies?
- Exploring state regulations which exist when working with controlled substances
- Implementing the manufacturing quotas which exist for these products