Infrastructure: Facilities and Shared Resources

A section of the FDA campus showing several buildings.

FDA’s laboratory complexes house more than 2,500 researchers and analysts whose work contributes to the development of new approaches, standards, and methods for evaluating the safety, efficacy, quality, and performance of the diverse and complex products the Agency regulates.

These facilities include a variety of specialized facilities to support laboratory research, including vivaria, biosafety level (BSL)-3 laboratory suites, Animal Biosafety Level (ABSL)-2 and -3 procedure rooms, and an anechoic chamber.

FDA also provides a variety of core facilities—many of which are supported by the FDA Shared Resources Program for Regulatory Science. Centers share costs to allow researchers access to state-of-the-art technology, equipment, facilities, experts, resources and information. Examples of FDA’s core facilities include the following: additive manufacturing of medical products (3D printing), microscopic imaging, flow cytometry, sequencing and other traditional biotechnologies, nanocore, electron microscopy, and advanced characterization technologies. Availability of core facilities to access expensive new technology provides FDA researchers a cost-effective way to stay current with the technologies FDA regulates and advance research efforts.

FDA developed High Performance Computing (HPC) environments that provide FDA researchers the capability to perform computationally intensive processing, modeling, and analysis. The HPCs enable bioinformaticians and computational experts to tailor development of algorithms and pipelines in support of specific scientific investigations or regulatory review of submissions. Across the Agency, scientists and researchers look at data in ways not previously possible, such as data visualization tools to find patterns in large data sets, informing the determination of risks and benefits with computational modeling and simulation and analysis of next generation sequencing methods to address scientific questions related to regulated products (such as detection and identification of the source of food-borne outbreaks).

In addition, the FDA Biosciences Library provides access to electronic journals, eBooks, over 50 online databases and research services such as assisting with systematic reviews and search strategies, available to staff at all FDA locations.

CROSS-CUTTING TOPICS

Minority Health and Health Equity	Women’s Health	Maternal Health	Pediatric Health
Oncology	Rare Diseases	One Health Initiative

EXPLORE THE FOCUS AREAS OF REGULATORY SCIENCE

Advanced Manufacturing	Antimicrobial Resistance	Artificial Intelligence	Biomarkers
Complex Innovative Trial Design	Digital Health Technologies	Empowering Patients and Consumers to Make Better-Informed Decisions	Food Safety
Increasing Access to Complex Generic Drug Products	Individualized Therapeutics and Precision Medicine	Medical Countermeasures and Preparedness for Emerging Infectious Diseases	Microbiome Research
Model-Informed Product Development	Novel Foods and Food Ingredients	Novel Technologies to Improve Predictivity of Non-clinical Studies and Replace, Reduce, and Refine Reliance on Animal Testing	Patient and Consumer Preferences and Perspectives
Patient-Reported Outcomes and other Clinical Outcome Assessments	Product Safety Surveillance	Quality of Compounded Drugs	Regenerative Medicine
	Substance Use Disorders	Technologies to Reduce Pathogen Contamination	Use of Real-World Evidence to Support Biologic, Device, and Drug Development and Regulatory Decision-Making

ADDITIONAL ORGANIZATIONAL INFORMATION

Office of the Chief Scientist

Office of Regulatory Science and Innovation

Research Capabilities, Tools, and Resources

Scientific Education, Training, and Communication

Infrastructure