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.

scientific collage with scientists, syringe, viruses, vaccine, microscope, and small group

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:

Regulatory Science Research

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.

Preparedness Research

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.

Innovative Technologies

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

Outreach and Professional 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.

FDA Standards

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.

One Health

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.

What's New

January 16: Learn more about the application process and next steps at the FY25 FDA Broad Agency Announcement (BAA) Question and Answer Session. Get FY25 BAA funding information and details at Sam.gov.
January 21: Join the Yale University/Mayo Clinic CERSI presentation on Optimizing the Assessment of Cancer Treatment Tolerability: Examination of Patient-Reported Symptoms & Physical Function.
January 23: Register to attend One Health in Action: Transdisciplinary Research to Address Health Threats at the Human-Animal-Environment Interface. Explore transdisciplinary approaches to understand community perceptions and knowledge of health risks.

Program Areas

Regulatory Science Research	Preparedness Research
Innovative Technologies	Outreach and Professional Development
FDA Standards	One Health