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  1. Advancing Alternative Methods at FDA

Alternative Methods Publications and Events

Advancing New Alternative Methodologies at FDA report cover, illustrating alternative methods publications and related events

On this page: Reports | Events and presentations | Guidance for industry | Publications | Related Information 



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.   

Events and presentations

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.   

Guidance for industry

FDA guidance documents that include use of alternative methods approaches are listed on the page Implementing Alternative Methods 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.  

Related Information 

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