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  1. Office of the Chief Scientist

Office of Regulatory and Emerging Science

ORES provides strategic leadership, coordination, and support for innovation in FDA’s regulatory science and preparedness research to advance FDA’s ability to protect and promote public health.

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Vision

A regulatory ecosystem that promotes and readily leverages advances in science and technology to protect and promote public health.

Mission

To further regulatory science, training, and engagement that supports the application of advances in science and technology to the development, viability, availability, and sustainability of FDA-regulated products.

Major Functions

ORES provides strategic leadership, coordination, and support for innovation in the U.S. Food and Drug Administration's (FDA) regulatory science and preparedness research to advance FDA’s ability to protect and promote public health in the following program areas:

  • Managing FDA-wide programs that support intramural and extramural regulatory science and innovation to address scientific and public health priorities.
  • Providing overarching support and guidance for FDA's animal research activities.

  • Advancing regulatory science under the FDA Medical Countermeasures (MCM) Regulatory Science Program to develop the tools, standards, and approaches to assess MCM safety, efficacy, quality, and performance.

  • Furthering regulatory science and training to help foster the adoption of cross-cutting, innovative science and technologies to advance medical product development.

  • Fostering FDA-wide professional development to help ensure that FDA meets the regulatory challenges posed by emerging science and technology.
  • Managing scientific working groups, comprised of scientists across FDA, to promote cross-cutting scientific coordination and collaboration and supporting scientific outreach and collaboration to engage stakeholders including other United States Government Agencies, global regulatory partners, academia, product developers, and consumers.

  • Leading the FDA Standards Program and Committee, per Staff Manual Guide (SMG) 9100.1, to facilitate internal coordination of FDA’s participation in standards development organizations and interagency engagement on and recognition of regulatory standards.

  • Supporting the FDA One Health Initiative to coordinate FDA-wide communication and cooperation on public health issues requiring an FDA-wide focus in the One Health arena.

Program Areas

collage of 9 photos including man removing frozen meal from microwave, MRI machine, dietary supplement, woman breaking cigarette in two, prosthetic leg, woman applying makeup, prescription medicine, dog eating, blood in vials

Regulatory Science Research

FDA scientist dividing plasma from individuals recently infected with dengue or West Nile viruses into smaller volume samples for distribution. These samples were part of a reference panel FDA created for qualified Zika test manufacturers, to determine if their tests can differentiate flaviviridae antibodies—that is, if the test can accurately show if a person was infected with Zika, dengue or West Nile, as antibodies for these viruses are very similar.

Preparedness Research

Human hand using futuristic tablet

Innovative Technologies

Group of people in training class.

Outreach and Professional Development

Futuristic data model

FDA Standards

One Health Initiative

One Health

 

Contact us: ORES@fda.hhs.gov



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