Advancing Regulatory Science
Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. On February 24, 2010, FDA launched its Advancing Regulatory Science Initiative (ARS), with the announcement of an FDA-NIH collaboration to speed the translation of research into medical products and therapies. A science-based initiative that is building on the success of existing FDA programs, like the Critical Path Initiative, ARS is expanding the medical product modernization model to encompass every dimension of regulatory science.
Clinical Trials and Human Subject Protection
The Good Clinical Practice Program is the focal point within FDA for Good Clinical Practice issues arising in human research trials regulated by FDA. In relation to Good Clinical Practice, the Good Clinical Practice Program:
- Coordinates FDA policies
- Contributes to leadership and direction through participation in FDA's Human Subject Protection/Bioresearch Monitoring Council
- Coordinates FDA's Bioresearch Monitoring program with respect to clinical trials, working together with FDA's Office of Regulatory Affairs (ORA)
- Contributes to international Good Clinical Practice harmonization activities
- Plans and conducts training and outreach programs
- Serves as a liaison with the HHS Office for Human Research Protection (OHRP) and other federal agencies and external stakeholders committed to the protection of human research participants
The Critical Path Initiative
The Critical Path Initiative (CPI) is FDA's national strategy for transforming the way medical products are developed, evaluated, and manufactured. Moving medical product development into the 21st-century is a colossal venture that cannot be undertaken by any one entity alone; it requires the close collaboration of all stakeholders. CPI was launched in 2004 to foster such collaboration and help drive innovation. CPI collaborations currently involve 84 government agencies, universities, industry leaders, and patient groups from 28 states and 5 countries on a raft of groundbreaking research projects.
The US Food and Drug Administration regulates a wide range of products, including foods, cosmetics, drugs, devices, and veterinary products, some of which may utilize nanotechnology or contain nanomaterials. The FDA has not established its own formal definition, though the agency participated in the development of the NNI definition of "nanotechnology." Using that definition, nanotechnology relevant to the FDA might include research and technology development that both satisfies the NNI definition and relates to a product regulated by FDA.
National Medical Evidence Generation Collaborative (EvGen Collaborative)
The National Medical Evidence Generation Collaborative (EvGen Collaborative) will work to integrate previously isolated data systems in a way that ensures that available information collected during healthcare-related activities (e.g., medical research, medical product development, clinical care) can be brought to bear for the benefit of all while guaranteeing security and patient privacy. EvGen will complement existing medical data sharing efforts and catalyze collaborations across all health sectors to prioritize identified practical applications of evidence generation. The goal is to improve healthcare while contributing to a dynamic learning healthcare system in which research is embedded in everyday medical practice and where all stakeholders—doctors, researchers, industry, government, patients, and families—can contribute to building the high-quality healthcare system for the future.
The Office of Pediatric Therapeutics Science and Research Activities include work with our international colleagues, academia, NIH, WHO and professional and advocacy organizations. Efforts are directed towards analysis of submitted pediatric trials, identified ethical and safety issues, and publication and dissemination of data and results.
Peer Review of Scientific Information and Assessments
The agenda describes all the planned agency peer reviews for influential scientific information and highly influential scientific assessments that are subject to the OMB Bulletin. The agenda contains key information as it becomes available including the preliminary title, subject and purpose of the planned report; the FDA operating division and office conducting the review and the name of the agency contact person; the peer review schedule; the use of a letter review, panel review or other mechanism; and the opportunities for public comment, if any are planned.
Real World Evidence
Real world data (RWD) and real world evidence (RWE) are playing an increasing role in health care decisions. This Website was designed to capture up-to-date information about the status of FDA activities around the development and use of RWD and RWE.
The goal of FDA risk communication is to help people make informed judgments about use of FDA-regulated products. FDA does this by interactively sharing risk and benefit information. It also provides guidance to regulated industries about how they can most effectively achieve this goal. To make informed decisions, people must have critical risk and benefit information that is adapted for their specific needs—when, where, and in the form they need to best understand and apply this information. Risk communication research guides FDA on how best to do this to support FDA’s capacity to conduct and oversee product-related communication and help inform policy decisions. In the end, this will make more useful information available to the public.
Women's Health Research
The Office of Women's Health (OWH) Science Program plays an integral role in promoting the scientific understanding of sex and gender differences in disease burden, treatment and response. OWH advocates for the study of sex differences in clinical research including clinical trials for FDA regulated products through adequate inclusion of women and sex based analysis. OWH accomplishes these goals through partnerships and collaborations with scientists within and outside the FDA.