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U.S. Department of Health and Human Services

About FDA

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Office of Strategic Programs (OSP)

Advises and assists the Director, CDER and other key agency officials concerning the performance of the FDA CDER planning, analysis, and business informatics activities.

Leads Center-wide strategic and operational planning and analysis.

Leads business process analysis and business process planning to ensure effective design, development and utilization of information systems, electronic, electronic data and analytic tools to optimize regulatory business processes.

Represents CDER in the FDA BioInformatics Board, ensuring that CDER's needs are reflected in enterprise initiatives, and vice versa.

Develops, installs, and monitors Center-wide business process and performance tracking systems.

Advises and assists the Director of CDER and other key Center and Agency officials concerning the planning and performance, strategic information management, and business process support, for CDER programs.

Serves as chief liaison to Office of the Commissioner for strategic and business information needs and process planning, and analysis of business needs, plans and performance results, including briefings for the FDA Commissioner, other FDA senior management, and external stakeholders, including HHS, OMB, Congress, patient and consumer advocates, and regulated industry.

 

Office Leadership

  • Theresa Mullin, Ph.D. Director
  • Mary Ann Slack, Deputy Director

 

Office Organization

  • Immediate Office
    • Data Standards Team
  • Office of Program and Strategic Analysis
    • Immediate Office
      • Benefit Risk Team
    • Analysis Staff
    • Planning and Evaluation Staff
    • Performance Analysis and Lean Management
  • Office of Business Informatics
    • Immediate Office
      • CDER Program Management Office
      • Innovation Management & Architecture Services & Solutions
      • Center IT Liaison Team
    • Division of Drug Quality and Compliance Services & Solutions
      • Drug Quality Solutions Team
      • Compliance Management Solutions Team
    • Division of Regulatory Review and Drug Safety Services & Solutions
      • Regulatory Review Management Solutions Team
      • Scientific Computing Solutions Team
      • Drug Safety Solutions Team
    • Division of Business Management Services & Solutions
      • Financial Management Solutions Team
      • Enabling Solutions Team
    • Division of Data Management Services & Solutions
      • eData Management Solutions Team
      • Data Management Services Team
      • Document Room Management Team

 

Contact Us

Office of Strategic Programs
10903 New Hampshire Avenue
White Oak Bldg 51, Suite 1100
Silver Spring, MD 20993
Phone: 301-796-3800