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.
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 Food and Drug Administration (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 Initiative (MCMi) Regulatory Science Program to develop the tools, standards, and approaches to assess medical countermeasures (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.
What's New
Apply for Funding – The application process for FY25 funding under the FDA Broad Agency Announcement (BAA) is now open. Submit your research and development proposals to support regulatory science and innovation by February 24, 2025. Get details at Sam.gov and plan to attend FDA BAA Day on November 14, 2024.
Program Areas
Regulatory Science Research |
Preparedness Research |
Innovative Technologies |
Outreach and Professional Development |
FDA Standards |
One Health |
Contact us: ORES@fda.hhs.gov