Appreciating the Nuances of the Approval Process for Controlled Substances

March 22, 2023 12:45pm

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