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  1. Center for Drug Evaluation and Research | CDER

Office of Program and Regulatory Operations


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 project management program
  • Provide operational and regulatory expertise for cross-functional initiatives and projects across OC and involving other Agency components
  • Develop and implement internal procedures and innovative processes to optimize work quality and efficiency
  • Manage OC’s controlled correspondence operations
  • Manage information technology governance across OC.  

Organization 

  • Program and Regulatory Operations Staff I 
  • Program and Regulatory Operations Staff II 
  • Program and Regulatory Operations Staff III 

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




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