Advancing New Alternative Methodologies at FDA
This report (PDF), published in January 2021, was developed by the Alternative Methods Working Group to highlight the significant progress FDA scientists have made in our product centers and offices in laying the groundwork for integrating alternative approaches into FDA regulatory programs. It demonstrates FDA’s strong commitment to reducing animal testing and to encouraging stakeholders to continue partnering with FDA to achieve this important goal.
Focus Areas of Regulatory Science
The Focus Areas of Regulatory Science (FARS) report, updated in 2022, outlines areas FDA has identified as needing continued targeted investment in regulatory science research to foster the development of innovative products, provide data and methods to inform regulatory decision-making, and improve guidance to sponsors. One focus area is novel technologies to improve predictivity of nonclinical studies and replace, reduce, and refine animal testing.
In November 2022, FDA published a new report, Successes and Opportunities in Modeling & Simulation for FDA. The report elucidates, in part, how and where Modeling & Simulation (M&S) is used across FDA, and the type and purpose of M&S used.
Scientists from across FDA routinely give presentations on topics related to advancing alternative methods. Examples are listed below, with the most recent at the top, and include links to materials or recordings where available. This list also includes upcoming events, as applicable.
- Advancing New Alternative Methods at FDA, given by Donna L. Mendrick, PhD at the MPS World Summit 2023 on June 27, 2023
- New Approach Methodologies for Use in FDA Food Safety Assessments, given by Suzanne Fitzpatrick, PhD, DABT, ERT at the ICCVAM Public Meeting on May 18, 2023
- FDA Grand Rounds: Microphysiological Systems as Novel Disease Models and Drug Development Tools given by Dayton Petibone, PhD and Qiang Shi, Ph.D. in March 2023
- Perspectives on Evaluating New Tools for Regulatory Use given by Donna L. Mendrick, PhD at the DIA 2022 session: The Translational Value of Animal Models in Rare Diseases in June 2022
- Advancing Alternative Methods for Regulatory Use given by David Strauss, MD, PhD at the FDA Science Board in June 2022
- Advancing Alternatives at FDA given by Donna L. Mendrick, Ph.D., at the IUTOX panel discussion at the Society of Toxicology Annual Meeting in March 2021
- Microphysiological Systems (MPS): Bridging Human and Animal Research - An FDA/CDER Perspective given by Amy Avila, Ph.D. at the National Academies Workshop in January 2021
- FDA, ICH, and the 3Rs given by Paul C. Brown, Ph.D. at the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) meeting in September 2020
- Predicting the Effects of Candidate Drugs: The Future given by Janet Woodcock, M.D. at the American College of Toxicology Annual Meeting in November 2020
- Microphysiological Systems to Assess the Functional Capacity of Cellular Therapy Products given by Kyung Sung at the FDA/IQ MPS Affiliate 2020 Workshop in February 2020
FDA guidance documents that include use of alternative methods approaches are listed on the page Alternative Methods in Action for easy reference. For more information about FDA guidance documents, including a full listing, see Search for FDA Guidance Documents.
FDA scientists from across the agency have contributed to a growing number of peer-reviewed journals on topics related to advancing alternative methods. A regularly updated list is available at: Publications Co-authored by FDA on Alternative Methods.
- FDA Seeks $8.4 Billion to Further Investments in Critical Public Health Modernization, Core Food and Medical Product Safety Programs (FDA Press Announcement, March 2022)
- FY 2023 President’s Budget Request for the FDA (March 2022)
- Advancing FDA’s Mission by Targeting Key Areas for Regulatory Science Investment and Innovation (FDA Voices, May 2021)