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  1. Focus Areas of Regulatory Science Report

Safety and Compliance

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FDA prioritizes the safety of all staff, as well as compliance with applicable laws and regulations including, but not limited to laboratory safety, use of animals, the environment, human subjects, and select agents and toxins. To ensure compliance with safety and other regulatory requirements, staff complete trainings on a regular basis relevant to their work duties or potential exposure to workplace hazards.

In addition, FDA promotes laboratory quality and adherence to quality elements among FDA researchers and regulatory personnel to achieve robust and reproducible findings. FDA researchers are encouraged to publish original research findings in scientifically accepted, peer-reviewed scientific journals after appropriate review and clearance. Quality programs are imperative to ensure the highest scientific rigor that leads to data-based decisions.

The Office of Laboratory Safety (OLS) partners with center and office staff to implement robust workplace health and safety programs and provide guidance to FDA laboratorians on laboratory quality management and environmental protection. OLS strives to support the Centers and Offices in identifying, quantifying, and controlling workplace hazards inherent to accomplishing the mission of FDA. Compliance with the National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) as well as use of hazardous biological agents and toxins is overseen by OLS through FDA’s Institutional Biosafety Committee. Likewise, compliance with the United States Nuclear Regulatory Commission requirements for working with radioactive materials is overseen by OLS through FDA’s Radiation Safety Program.

OLS works in conjunction with Employee Safety and Occupational Health (ESOH) Staff, who oversee occupational health services, ergonomics, and Automated Emergency Defibrillator (AED) programs. At most FDA properties, FDA employees oversee facilities maintenance and engineering activities and conduct preventive maintenance and annual inspections of building equipment and systems. The activities among these groups are interwoven to support safe research and the attainment of regulatory goals.

FDA researchers follow and uphold principles of scientific integrity to promote an environment of robust scientific debate where integrity of information is ensured, all views are considered, and scientific decisions are protected from political influence. This protects FDA’s ability to reach sound decisions and to retain the public’s trust. The Office of Scientific Integrity works to ensure that FDA's policies and procedures are current and applied across the Agency; resolves scientific disputes that may arise internally or externally and that are not resolved at the Agency's center levels; and advise the Chief Scientist and other senior FDA leaders on appropriate responses. FDA provides author services and resources to FDA researchers to ensure that they are submitting articles to reputable journals with rigorous peer review instead of predatory publishers.

FDA researchers may occasionally conduct research involving human subjects. FDA’s Institutional Review Board is generally responsible for overseeing the protection of human subjects in FDA-conducted research, consistent with applicable HHS and FDA regulations, such as the HHS Policy for Protection of Human Subjects (45 CFR part 46), Protection of Human Subjects (21 CFR part 5021 CFR part 50) and Institutional Review Boards (21 CFR part 5621 CFR part 56).

While FDA strives to reduce the use of animal tests, animal tests still are often needed to support development of FDA-regulated products. FDA has three (3) animal programs to support the FDA mission, each with its own American Association for Accreditation of Laboratory Animal Care accreditation, Attending Veterinarian, Institutional Official, and Institutional Animal Care and Use Committee. In addition, each of FDA’s animal programs follow the policies of the National Institutes of Health Office of Laboratory Animal Welfare and obtain assurances to demonstrate their compliance. OCS provides general guidance and develops Agency-wide policies supporting the safe care and use of animals through the Animal Welfare Council.




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



Research Capabilities, Tools, and Resources

Research Management and Collaborations Technology Transfer and Public-Private Partnerships Physical Standards and Reference Materials Intramural Grant Programs Extramural Funding Mechanisms

Scientific Education, Training, and Communication

Fellowship and Training Opportunities Professional Development and Continuing Education Communication and External Meetings


Facilities and Shared Resources Safety and Compliance



Office of the Chief Scientist

Office of Regulatory Science and Innovation

Contact Us: FARS@fda.hhs.gov


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