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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  6. Scientific Education, Training, and Communication
  1. Focus Areas of Regulatory Science Report

Scientific Education, Training, and Communication

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Fellowship and Training Opportunities

FDA offers different types of internships, fellowships, and training opportunities to national and international students and postgraduate scientists as well as college and university faculty members. Centers also administer programs and targeted trainings to researchers and scientists at different career stages. For example, with the intent to educate the next generation of scientists, FDA hosts the Oak Ridge Institute for Science and Education (ORISE) Research Participation Program, which allows high school, college, and graduate students, recent graduates, post-doctoral scientists and university faculty to actively engage in research experiences with an FDA scientist who serves as a mentor. Another program, the FDA-National Cancer Institute Inter-Agency Oncology Task Force Joint Fellowship Program trains scientists in research and research-related regulatory review policies, and regulations to develop a skill set relevant to both the review and research areas. Additionally, FDA’s Service Fellowship Program gives scientists the opportunity to accelerate and enhance their careers by working closely with leading authorities in FDA-related research while also learning about FDA regulatory review. FDA OMHHE also hosts a Genomic Science and Health Equity Post-Doctoral Fellowship in collaboration with the National Human Genome Research Institute at NIH.

Professional Development and Continuing Education

FDA provides resources and opportunities for research and review staff to remain current on key scientific advances, including providing training opportunities that translate knowledge from internal research programs to reviewers to inform regulatory review, policy, and regulatory decision-making, through a variety of internal seminar series.

Many scientific working groups also host educational workshops, seminars, or training activities to ensure FDA’s scientific staff remain current on a variety of relevant topics to support review activities. For example, the FDA Genomics Working Group has an education subcommittee which provides educational opportunities in the use, analysis, and understanding of next generation sequencing for many years. Centers also have research-related governance committees, centers of excellence (e.g., immunology, oncology) and working groups that provide recommendations and guidance, research portfolio investments, and collaborate with the SSC and FDA scientific working groups.

With FDA’s scientific and technical staff making up more than 65 percent of FDA’s workforce across a multitude of disciplines, FDA provides staff with a wide range of professional development opportunities to stay current with the latest advances in science and technology. FDA staff have access to FDA’s scientific professional development calendar on the Agency’s intranet, which provides a comprehensive listing of relevant Agency-wide scientific professional development events sponsored by FDA and FDA partners (e.g., CERSI Program). In addition, researchers attend relevant trainings to stay compliant with regulatory and safety mandates.

Internally, FDA hosts lectures, workshops, poster sessions, and scientific experts from external organizations to share best practices and information. FDA also discusses emerging science topics in seminar series and journal clubs providing a forum for staff to stay current about scientific literature. Monthly, the FDA hosts the public educational series of the FDA Grand Rounds, presentations that highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health.

Additionally, the FDA hosts the biannual FDA Science Forum, which offers the public a first-hand look at how FDA’s researchers use novel science and technologies to inform FDA’s regulatory decision-making through roundtable discussions, poster sessions, and interactive presentations.

FDA also prioritizes continuing education for its staff and external stakeholders. FDA’s Continuing Education (CE) program offers medical, pharmacy, and nursing CE credit for lectures, courses, and scientific rounds through the CE Portal. The FDA Learning Portal provides educational resources related to FDA’s regulatory, product quality, safety responsibilities, and research for students, academia, and industry. FDA also provides free online trainings to state, local, and tribal regulatory partners.

Communication and External Meetings

OCS provides cross-agency scientific coordination (e.g., for emerging technologies, scientific issues involving multiple Agency components, standards coordination, and science communication) through the SSC and FDA scientific working groups. The SSC provides guidance to the Agency and center leadership on cross-cutting regulatory science issues, including planning, reporting, programs, policies, and communication. Chartered scientific working groups endorsed by the SSC and administered by the OCS serve FDA senior management as a scientific information resource, while also providing a forum for cross-center and office communication and fostering collaborations. The goals of the working groups include the following: communicate and share information among centers, when needed, or as feasible, coordinate scientific projects, and promote collaboration and exchange of resources and expertise. For example, the Emerging Sciences Working Group leverages scientific expertise and resources to conduct long-range horizon scanning to advise Agency and center leadership on how emerging issues and cross-cutting scientific advances may affect FDA preparedness and trans-Agency activities.

FDA also engages with external partners across the globe to host public workshops, meetings, (including advisory committee meetings), and conferences covering a wide range of topics such as medical devices, tobacco products, vaccines, cell and gene therapy products, and combination products to share scientific expertise, research results, and develop future collaborations. For example, FDA released an updated Nanotechnology Task Force Report in advance of the annual Global Summit on Regulatory Science (GSRS) meeting in 2020. The GSRS is an international venue for discussion of innovative technologies and partnerships to enhance translation of basic science into regulatory applications within the global context.

FDA scientists and trainees stay up to date with the latest scientific knowledge and skills, while also sharing the results of their research by attending and presenting at relevant external scientific and professional society meetings, conferences, and courses.

 

 

CROSS-CUTTING TOPICS

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

Infrastructure

Facilities and Shared Resources Safety and Compliance

 

ADDITIONAL ORGANIZATIONAL INFORMATION

Office of the Chief Scientist

Office of Regulatory Science and Innovation

Contact Us: FARS@fda.hhs.gov

 

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