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  1. Center for Drug Evaluation and Research | CDER

Controlled Substance Program


The Controlled Substance Program (CSP) is overseen by the Associate Director for Controlled Substances and aims to promote the public health by minimizing risks associated with problematic use of controlled substances while enabling appropriate access for medical use.

CSP’s core functions include:

  • Proactively identifying and analyzing emerging issues with controlled substances and related strategies and initiatives that could help drive appropriate access
  • Providing technical expertise on drug assessment and scheduling, and consultation services for specific drug applications
  • Serving to coordinate and support CDER’s work on controlled substance policies and programs with internal and external stakeholders
  • Communicating with external stakeholders, including other government agencies, industry, and academia, on emerging issues and ongoing initiatives and policies at FDA around controlled substances

CSP comprises the Controlled Substance Staff (CSS), a group focused on the assessment of the abuse potential of drugs; and Controlled Substance Initiatives (CSI), a group focused on proactive activities and policies to identify, mitigate, and manage emerging issues with controlled substances.

More information on CSS can be found here.

Organization and Contacts

Marta Sokolowska, Ph.D., Associate Director for Controlled Substances, Office of the Center Director
Dominic Chiapperino, Ph.D., Director, CSS




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