Appreciating the Nuances of the Approval Process for Controlled Substances
Delia Deschaine
FDA/DEA Regulatory Attorney - Member of the Firm (Partner)
Epstein Becker & Green PC
(Washington, DC)
- Defining the term “controlled substance”?
- Reviewing the scheduling process for both approval as well as postmarketing 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