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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  6. Office of Computational Science
  1. CDER Offices and Divisions

Office of Computational Science

Who We Are:

The Office of Computational Science (OCS) drives the modernization of CDER’s scientific review process through the implementation of tools, services, and training to enable reviewers to apply their expertise to information. We provide CDER reviewers innovative and reliable solutions that improve and strengthen the scientific review process by integrating data, tools, and training.

What We Do:

  • Build solutions that drive New Drug Modernization, promote access to quality data, and optimize data analysis capabilities to enhance review transparency, efficiency, consistency, and predictability.
  • Engage stakeholders in developing and delivering effective tools, technologies, services, and training to enhance their ability to meet CDER’s mission.
  • Enhance the accessibility of study data by providing automatic, seamless connection to CDER tools and services, making quality, validated data readily available to reviewers.
  • Connect CDER staff to the scientific computing resources and technologies needed to drive efficient analysis and cost-effective solutions.
  • Deliver solutions that streamline BIMO workflow for reviewers and inspectors throughout the inspections process, automate manual tasks to minimize data entry and redundant processes for BIMO stakeholders, and provide reporting and analytic capabilities to enable faster and stronger decision-making.
  • Spearhead the CDER Innovation Board to harness subject matter expertise across FDA and provide a knowledge capture framework to guide and advance innovation projects.
  • Offer cloud-enabled innovation space for tools, technologies, and data exploration, providing a platform for technologists and innovators to prototype, test, and implement solutions to CDER’s pressing business challenges.
  • Collaborate with industry, academia, and other external partners through our work with PHUSE, CDISC and BioCelerate, which enables us to share insights and subject matter expertise and pursue innovative solutions in support of regulatory review.

Office Organization:

Immediate Office (OCS-IO)
Office Director: Lilliam Rosario, Ph.D.    
Deputy Director: Isaac Chang, Ph.D.

Division of Tools Technology & Innovation (DTTI)
Division Director: Lilliam Rosario, Ph.D. (Acting)

Division of Regulatory Review & Research (DRRR)
Division Director: Jose Delgado Donayre, M.D.

For more information, contact Office of Computational Science.



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