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  1. CDER Offices and Divisions

Controlled Substances Program

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The Controlled Substances Program (CSP) is overseen by the Deputy Center Director for Substance Use and Behavioral Health 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 Substances Initiatives (CSI), a group focused on proactive activities and policies to identify, mitigate, and manage emerging issues with controlled substances.

More information on Controlled Substance Staff.

Leadership

Marta Sokolowska, Ph.D., Deputy Center Director for Substance Use and Behavioral Health, Office of the Center Director

Latest News

Date Title
11/20/2024 Controlled Substances Program Newsletter, November 2024
5/7/2024 Controlled Substances Program Newsletter, May 2024


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