By RADM Denise Hinton, Chief Scientist, and Tina Morrison, Ph.D., Director, Office of Regulatory Science and Innovation
We live in an era of rapidly changing technological advancements that enable science to evolve at an unprecedented pace. At the US Food and Drug Administration, we rely on our scientific and technical experts to make sound, science- and evidence-based regulatory decisions to protect and promote public health. As we march forward, the FDA aims to deepen its connections among external stakeholders and experts, and our own scientists. In this post, you will learn about the way we are reshaping our regulatory science programs to facilitate these interactions.
RADM Denise Hinton
The FDA’s Strategic Plan for Advancing Regulatory Science identified nine science priority areas where it considered new or enhanced engagement would be essential to the continued success of the FDA’s public health and regulatory mission. Over the past decade, the Office of the Chief Scientist has been integral to executing this plan. Its Office of Regulatory Science and Innovation (ORSI) has launched and supported cross-agency collaborative programs aligned with these priorities. The Intramural Research Grants Program and Scientific Working Groups such as the Alternative Methods Working Group are two examples.
Seeking to foster innovation through external collaboration, ORSI also launched the FDA’s Advancing Regulatory Science Broad Agency Announcement and established our academic Centers of Excellence in Regulatory Science (CERSI), whose priorities have also been driven by the strategic plan. These collaborations and a host of others across the agency, along with interactions with national and global scientific organizations, have increased our understanding of emerging science and technology and have further strengthened our ability to make sound science-based, data-driven regulatory decisions.
Evolving FDA’s regulatory science research programs
This year, the FDA published the 2021: Advancing Regulatory Science: Focus Areas of Regulatory Science Report (FARS Report) to communicate the importance and impact of the FDA’s regulatory science research activities and to identify cross-cutting areas that need sustained or new investment to fulfill the FDA’s mission. The research examples presented in the FARS Report, in turn, highlight the FDA’s response to the evolving science and technology reflected in FDA-regulated products since 2011.
Tina Morrison, Ph.D.
Although the FDA centers and offices structure their focused research portfolios to address priority needs within their regulated areas, points of intersection exist that can benefit from collaborative approaches and joint agency commitment. To address these cross-cutting needs, the FDA formed an agency-wide committee to survey its research portfolios. The committee’s goal is to evaluate and determine which scientific areas of interest are cross-cutting and vital to the FDA, and how best to communicate this to internal and external stakeholders.
The FARS Report’s flexible structure accommodates updates and revisions to align regulatory science research with scientific advancements and captures evolving priorities and regulatory needs.
Focus areas and strategic initiatives of the FARS report
The FARS Report identifies 22 cross-cutting focus areas (FARS) that the FDA believes need continued investment and innovation by agency scientists and from our external stakeholders The FARS is not a comprehensive list of all regulatory science research conducted at the FDA. Rather, these focus areas generally encompass regulatory science affecting more than one center or office.
The FARS are organized across three strategic initiatives that the FDA identified in 2020, plus a fourth initiative that the FDA identified as a critical regulatory science need, especially in light of the COVID-19 pandemic:
Increasing Choice and Competition through Innovation;
Unleashing the Power of Data;
Empowering Patients and Consumers;
Public Health Emergency Preparedness and Response.
Each of the FARS comprises two parts: a discussion of its importance to the FDA, and a list of current or ongoing research examples related to that focus area that supports the FDA’s mission.
The FDA has invested resources to tackle the needs identified in each of the FARS and has research capabilities, scientific training and education plans, and infrastructure in place for agency scientists. Additionally, the FDA encourages research that continues to serve and advance the needs of specific populations, such as children, racial and ethnic minorities, women, those with rare diseases, and other diverse groups, thereby advancing health equities.
“Call to Action”
The FDA strongly encourages experts working in one of the FARS to review the “Importance to FDA” statement and the examples contained in the FARS Report, to determine whether an opportunity exists to collaborate with the agency.
Stakeholder engagements with the FDA Science Board and the CERSIs are just some of the initial interactions that the FDA aims to harness to ensure we are staying ahead of the changing regulatory science needs in a timely manner. We will keep our stakeholders abreast of our efforts and plan to showcase future accomplishments and ongoing work in regulatory science, research and innovation.
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