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  1. Center for Drug Evaluation and Research | CDER

Office of Program and Regulatory Operations in Compliance

Who We Are
The Office of Program and Regulatory Operations (OPRO) leads and manages operational infrastructure for the Office of Compliance (OC) relating to project management and process management.

What We Do

  • Lead OC’s systematic project management program.
  • Develop and implement internal procedures and innovative processes to optimize work quality and efficiency.
  • Manage information technology (IT) governance across OC.
  • Oversee FDA’s drug registration and listing database (eDRLS) and manage associated regulatory and policy issues, and conduct stakeholder outreach regarding eDRLS issues.
  • Manage cross-functional projects involving other agency components.

Contact Us
Email: CDERCompliance@fda.hhs.gov

Phone: 301-796-3100

Office of Compliance
10903 New Hampshire Avenue
Bldg. 51, Room 5278
Silver Spring, MD 20993-0002