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  1. Advancing Regulatory Science

Intramural Regulatory Science Programs

ORES funds research by internal staff to advance the regulatory mission and promote public health.

 

Regulatory Science and Innovation

The Office of Regulatory and Emerging Science (ORES) manages four FDA programs that provide funding to support intramural regulatory science and innovation to address scientific and public health priorities. Our goal is to advance discovery and innovation in regulatory science to help translate cutting-edge science and technology into safe and effective medical products.

ORES’s role is to coordinate the review and granting of competitive intramural research awards under the following research areas:

  1. Medical Countermeasures (MCMs) - to help translate cutting-edge science and technology into safe and effective MCMs needed to respond to chemical, biological, radiological, nuclear threats and emerging infectious diseases.
  2. Minority Health and Health Equity - to advance minority health and health equity, the understanding of health disparities, and to provide future directions for research that contributes to regulatory decision making.
  3. Cross-Agency Regulatory Science (CARS) - to advance innovative research that shows strong promise in addressing major regulatory science needs that will advance FDA’s regulatory mission and public health.

Leadership and funding for the Minority Health and Health Equity Intramural Regulatory Science Challenge Grant Programs is provided by the Office of Minority Health & Health Equity

Leadership and funding for the MCM and CARS Intramural Regulatory Science Challenge Grant Programs is provided by ORES.


Cross-Agency Regulatory Science (CARS) Intramural Regulatory Science Challenge Grant Program

ORES provides funding to support innovative intramural regulatory science research that shows strong promise in addressing major regulatory science needs that will advance FDA’s regulatory mission and public health.

ORES prioritizes intramural research projects that demonstrate cross-agency collaboration, exceptional and innovative ideas to advance regulatory science, broad impact for more than one FDA office, excellent scientific merit to further regulatory science efforts of other stakeholders, and have a practical application and the potential for regulatory impact. Additional consideration is given to proposals that address Alternative Methods, One Health, or Nanotechnology.

Project Awardee Lead Center Collaborators
Development of a novel pathogen reduction technology (PRT) for stored human whole blood as an alternative to current PRTs available or in the pipeline Atreya, Chintamani D. CBER NCTR
Rapid Confirmation of Microbial Isolates Using Whole Genome Sequencing Neal-McKinney, Jason ORA OCS
Advancing Quality and Safety Assessment of Synthetic Oligonucleotides with Emerging Precision Analytics and New Alternative In-Vitro Methods Aided by Machine Learning for Improved Predictability Yang, Kui CDER NCTR
Uncertainty Quantification in AI-enabled Classification Models Cao, Qian CDRH CVM, CDC
Design and Optimization of Analytical Methods for Handheld and Field Portable Devices to Detect Active Pharmaceutical Ingredients (APIs) in FDA-Regulated Products at Remote Sampling Sites Kimani, Martin ORA CDER
AnimalGAN: A Generative Artificial Intelligence Model Complementary to Animal Studies Tong, Weida NCTR Welch, Lacinda
Chemical Contaminants in Soil -Assessing Uptake and Bioaccumulation in Fresh Produce and Subsequent Impact on Human Health Trujillo, Socrates CFSAN OCS, OSTP, NIH
One Health AMR Monitoring: Standardizing the detection and reporting of critically important antimicrobial resistance (AMR) Andrea Ottesen CVM  
Development of An Analysis Pipeline for the Assessment of Reference Databases Used in Microbial Metagenomic Analysis Software David Erickson CDRH  
Assessing and mitigating the bias in applying Artificial Intelligence (AI) based natural language processing (NLP) of drug labeling documents Leihong Wu NCTR Welch, Lacinda
Synthesis and Characterization of a Newly Identified Arsenic Species Present in Rice Grain Kevin Kubachka ORA  
Development of Specific and Sensitive Diagnostic Devices for Emergent Flaviviruses Maria Rios CBER  
Active safety surveillance of cannabis-derived products using electronic health record (EHR) data Silvia Perez Vilar CDER  

Resources For You

Contact the Office of Regulatory and Emerging Science: ORES@fda.hhs.gov.

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