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  1. CDER Offices and Divisions

Office of Strategic Programs


The Office of Strategic Programs (OSP) serves the Center Director, and the super office directors who lead major operations involved in regulatory oversight of human drugs. OSP's functional capabilities include strategic planning and management, negotiation with major external stakeholders over future work commitments and resource commitments, and process and program design and management.​​​​

Director: Sridhar Mantha, M.B.A., M.S., B.Tech.
Deputy Director: Jose Galvez, M.D.
Deputy Director of Operations: Tessa Brown, DHSc, MPH

What We Do:

  • Lead Center-wide strategic and operational planning, performance analysis, and implementation
  • Steer CDER-wide technological advancements and initiatives by evaluating existing data and analytic systems, canvassing innovation in data management systems, leading implementation of new IT portfolios, and managing CDER’s IT budget.
  • Promote regulatory data standardization and harmonization in collaboration with other FDA offices, domestic and international regulatory bodies, and other standard setting organizations to increase efficiency and sharing of key data elements to make swift regulatory decisions. 
  • Conduct and maintain official CDER regulatory data for internal and external analysis, communications, and official reporting.
  • Serve as an internal consulting service to provide programmatic support, measure and conduct performance analysis, establish consistent best practices, and implement key initiatives.

Office Organization:

OSP has a diverse portfolio of subject matter experts, including economists, data scientists, process improvement experts, programmers, performance appraisers, crowdsourcing experts, doctors, pharmacists, and programmatic support experts, to name a few.

  • Business Informatics Governance Staff (BIG)
    The Business Informatics Governance (BIG) team maintains a comprehensive list of and evaluates all CDER’s informatics-related projects to maximize CDER’s technological resources and minimize duplication.
     
  • Data Standards Staff (DSS)
    The Data Standards Staff (DSS) provides technical expertise for the planning, management, and execution of CDER’s initiatives to standardize and optimize the use of regulatory data in collaboration with internal and external stakeholders.
     
  • Program Management Administrative Staff (PMAS)
    The Program Management Administrative Staff (PMAS) services and manages all arenas of administrative operations including: budget, travel, facilities management, human resources and personnel operations to OSP offices.

Office of Business Informatics (OBI)
The Office of Business Informatics (OBI) supports CDER’s regulatory decision-making by identifying, implementing, and managing CDER-wide informatic systems to meet business needs.

Office of Program & Strategic Analysis (OPSA)
The Office of Program and Strategic Analysis (OPSA) provides a range of analytical services, project management support, and strategic and operational planning for CDER offices to improve the effectiveness and efficiency of regulatory functions.

Contact Us:

Office of Strategic Programs
White Oak Building 32, Suite 4100
10903 New Hampshire Avenue Silver Spring, MD 20993
Email: CDER_OSP_IO@fda.hhs.gov | 301-796-3800




 
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