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# Collaborations Needed to Advance Regulatory Science: FDA
- URL: https://www.fdaweb.com/collaborations-needed-to-advance-regulatory-science-fda/
- Published: 2021-05-17T12:00:00.000Z
- Updated: 2026-09-14T16:59:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149334

FDA says it wants to improve its interactions among external stakeholders and experts, and its own scientists to advance regulatory science. Writing in an [online post](https://www.fda.gov/news-events/fda-voices/advancing-fdas-mission-targeting-key-areas-regulatory-science-investment-and-innovation?ref=fdaweb.com), FDA chief scientist and **Denise Hinton** *and Office of Regulatory Science and Innovation (ORSI) director* **Tina Morrison**update stakeholders on its [Advancing Regulatory Science: Focus Areas of Regulatory Science Report](https://www.fda.gov/science-research/advancing-regulatory-science/focus-areas-regulatory-science?ref=fdaweb.com).

The report identifies four regulatory science strategic initiatives for 2021 — unleashing the power of data; increasing choice and competition through innovation; empowering patients and consumers; and public health emergency preparedness and response. It was developed to “identify and communicate priority areas where new or enhanced investments in regulatory science research capacity are essential to support FDA’s regulatory and public health mission,” the agency says. Increased research in these areas is intended to aid in innovative product development, provide data to inform regulatory decision-making, and improve guidance to sponsors, it says.

The report discusses the importance of real-world evidence (RWE) in regulatory decision-making, including its ability to provide “fit-for-purpose” clinically meaningful information about the safety and effectiveness of medical products (begins page 39). It outlines several projects that will advance the roles such data can play in supporting the evaluation of a product’s safety and effectiveness, it says. For example, FDA is funding a RWE demonstration project called “Randomized Controlled Trials Duplicated using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology.” The project will attempt to duplicate the results of recently completed randomized controlled clinical trials relevant to regulatory decision-making using RWE, based on health insurance claims data, FDA says.

The two FDA officials note that while 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,” they write. “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.”

FDA encourages experts working in one of the four focus areas to determine whether a collaboration opportunity is warranted. “Stakeholder engagements with the [FDA Science Board](https://www.fda.gov/advisory-committees/committees-and-meeting-materials/science-board-food-and-drug-administration?ref=fdaweb.com) and established \[[Centers of Excellence in Regulatory Science](https://www.fda.gov/science-research/advancing-regulatory-science/centers-excellence-regulatory-science-and-innovation-cersis?ref=fdaweb.com)\] 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,” the officials say.