Innovative Technologies Regulatory Science Research
ORES funds intramural and extramural regulatory science research to support adoption of cross-cutting innovative and emerging technologies.
On this page: Research areas | Current projects | Completed projects | Resources for You
To develop the tools, standards, and approaches necessary to support the adoption of innovative and emerging technologies, the Office of Regulatory and Emerging Science (ORES) provides funding in high-priority regulatory science research areas for internal FDA scientists as well as for external research groups that align with U.S. Government priorities.
Our goal is to strengthen the FDA’s ability to respond to public health emergencies, increase manufacturing flexibility and improve supply chain resilience to prevent and address product shortages, and ensure the safety, efficacy, and quality of FDA-regulated products.
Extramural Funding
ORES funds extramural research for emerging and innovative technology-related regulatory science with several mechanisms, primarily using the FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science. Full application information and instructions for the current BAA are available at SAM.gov.
Intramural Funding
Funding for intramural emerging technology regulatory science is primarily provided through competitive awards under the Medical Countermeasures Regulatory Science Challenge Grants Program.
Priority Research Interest Areas
- Innovative and emerging technologies such as advanced manufacturing- including continuous, additive, and smart manufacturing
- Supply chain resilience including technologies to prevent or mitigate medical product shortages and/or speed time to market
- Alternative methods for regulatory use such engineered tissues (e.g., using scaffolds and cells to form biologically active tissues), artificial Intelligence (e.g., using computer (aka in silico) approaches), complex In Vitro models (e.g., alternative organisms such as Zebrafish and C. elegans), and novel in vitro systems (e.g., microphysiological systems (MPS), including organs-on-chips)
ORES Collaborations
In addition to funding high-impact projects, the ORES Advanced Manufacturing Program is active in external and interagency collaboration activities. These activities allow the FDA to contribute to ongoing work outside of the Agency, including standards development and industry roadmaps, as well as learn from industry stakeholders about the state-of-the-art science.
Project | Partner(s) |
---|---|
VHA Digital Stockpile National Response Network MOU | Veterans Health Administration (VHA) |
Digital Stockpile and National Response Network Roundtable | VHA, Radiological Society of North America (RSNA), America Makes |
America Makes and ANSI Additive Manufacturing Standardization Collaborative (AMSC) Roadmap | America Makes, American National Standards Institute (ANSI) |
Current Extramural Projects
Project | Awardee |
---|---|
Initiative to benchmark and profile monoclonal antibody and large biomolecule stability |
National Institute of Standards and Technology (NIST) |
Applying Additive Manufacturing for Continuous Production of Extracellular Vesicle Products |
CERSI- University of Maryland |
Noninvasive PAT for Manufacturing Automation |
University of Maryland |
An X-ray based inline probe for real-time process monitoring of the crystallization of active pharmaceutical ingredients (API) in manufacturing drug products | University of Maryland |
Completed Extramural Projects
Project | Awardee |
---|---|
FDA Advanced Manufacturing Evaluation |
Booz Allen Hamilton |
Analysis of the Advantages of and Barriers to Adoption of Smart Manufacturing for Medical Products |
MxD (The Digital Manufacturing and Cybersecurity Institute) and IAAE |
Assessing the Role of Additive Manufacturing in Support of the U.S. COVID-19 Response |
America Makes, National Center for Defense Manufacturing & Machining |
Landscape Analysis of Adoption of Advanced Manufacturing in Non-Medical Industries |
Booz Allen Hamilton |
Completed Intramural Projects
Project | Awardee | Center |
---|---|---|
Improving Influenza Vaccine Reagent Production | Jerry Weir | CBER |
Enusha Karunasena | CDRH |
Resources For You
- 3D Printing of Medical Devices (CDRH)
- Impact of Continuous Manufacturing Processes on the Viral Safety of Therapeutic Proteins (CDER)
- CDER Researchers Explore the Promise and Potential of 3D Printed Pharmaceuticals (CDER)
- Impact Story: Regulatory Science is Strengthening U.S. Drug Product Manufacturing (CDER)
- Modernizing the Way Drugs Are Made: A Transition to Continuous Manufacturing (CDER)