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U.S. Department of Health and Human Services

About FDA

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Office of Program and Strategic Analysis (OPSA)

Conducts a wide range of qualitative and quantitative analyses to answer key questions of Center operations, informing internal strategy and decision-making, as well as Center strategy with respect to the external stakeholder environment.

Provides project management and other technical services to direct or coordinate implementation of significant Center initiatives and to improve the efficiency and effectiveness of Center resources and key business processes.

Evaluates impact of external factors (e.g. industry behavior, proposed legislation) on Center programs. As necessary, recommends new initiatives or changes in existing programs and priorities.

Conducts program evaluation studies and special operational analyses to assess the impact of Center initiatives to improve effectiveness and efficiency.

Leads and coordinates Center-wide development of strategic and operational plans.

 

Office Leadership

  • Patrick Frey, MPP, Office Director
  • Marta Wosinska, Ph.D., Analysis Staff Director
  • Yashika Rahaman, Ph.D., Performance Analysis & Lean Management Director
  • Andrew Kish, MSPPM, Planning and Evaluation Staff Director (Acting)

 

Description of Organizational Units

Immediate Office

 

Decision Support and Analysis Team

Advances the Center’s efforts and meets commitments in PDUFA V for development of a benefit-risk framework to be used in regulatory decision-making.

 

Analysis Staff

Serves as the Center technical expert and knowledge resource regarding the commercial business and economics of drug development (branded drugs and biologics, generics, biosimilars, and OTC products) to inform Center leadership of industry trends and to support decision-making.

Conducts a wide range of analyses of regulated industry trends that may be relevant to Center operations and policies, and other market and public policy factors that may have implications on the strategic and operational environment of the Center.

Conducts special quantitative and qualitative data analysis, as requested; applying operations research, statistical analysis, economic analysis, cost-benefit and decision analysis; to support senior management decisions.

Evaluates impact of proposed policies on external stakeholders to support Center, Agency, and Department decision-making.

Conducts Center regulatory policy impact analyses, including alternative courses of action or identified policy options for management consideration.

 

Planning and Evaluation Staff

Conducts a wide range of qualitative and quantitative analyses to answer key questions of Center operations, informing internal strategy and decision-making, as well as Center strategy with respect to the external stakeholder environment.

Provides project management and other technical services to direct or coordinate implementation of significant Center initiatives and to improve the efficiency and effectiveness of Center resources and key business processes.

Evaluates impact of external factors (e.g. industry behavior, proposed legislation) on Center programs. As necessary, recommends new initiatives or changes in existing programs and priorities.

Conducts program evaluation studies and special operational analyses to assess the impact of Center initiatives to improve effectiveness and efficiency.

Leads and coordinates Center-wide development of strategic and operational plans.

 

Performance Analysis and Lean Management

Serves as the Center coordinator and focal point for Lean Management and provides consultation on application of Lean Management concepts to Center operations. Conducts lean management analyses on identified cross-cutting internal processes, recommending business process improvements as appropriate to improve efficiency of Center operations.

Supports senior management through centralized program performance reporting for branded drugs and biologics, generics, and biosimilars. Determines Center reporting requirements as regulations, policies, and program needs change.

Serves as Center technical expert in development of specialized and informative management reports using the corporate databases.

Provides additional data analysis and information to address specific questions and issues using the corporate databases and other appropriate data sources.

Coordinates data and information requests (e.g., for Press Inquiries, Freedom of Information (FOIs), Congressional reports, General Accounting Office (GAO) and Office of Inspector General (OIG) studies).

 

Contact Us
Office of Planning and Analysis
10903 New Hampshire Avenue
White Oak Building 51, Suite 1100
Silver Spring, MD 20993
Phone: 301-796-3800