Intramural Regulatory Science Programs

 

The Office of Regulatory and Emerging Science (ORES) manages three 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. 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 MCM and CARS Intramural Regulatory Science Challenge Grant Programs are provided by ORES.

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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.

Current Projects

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

• Intramural Grant Programs | FDA
• Intramural Research | FDA
• Focus Areas of Regulatory Science - Approach | FDA

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