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  1. About Science & Research at FDA

Advancing Alternative Methods at FDA

FDA is working to advance alternative methods for regulatory use. Alternative Methods have the potential to provide more timely and more predictive information to assess certain aspects of FDA-regulated products while also replacing, reducing and/or refining animal testing (the 3Rs).


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In this section

Computers, code, and stethoscope, representing alternative methods. An alternative method generally refers to a testing strategy different from the traditional approach.

About Alternative Methods 

What are alternative methods, and why is FDA advancing them for regulatory use? Learn more, including examples of alternative methods and definitions of key terms. 

Scientist in lab with computer and data, representing implementation of alternative methods to help replace, reduce, and refine animal testing

Implementing Alternative Methods

Agency-wide efforts for advancing development, qualification, and implementation of alternative methods for product testing.
Publications on alternative methods co-authored by FDA scientists
Publications on alternative methods co-authored by FDA scientists

Publications and Events

See what’s new from FDA on alternative methods, including publications, presentations, guidance documents, events, and related materials.

Scientists collaborating using a white board, illustrating alternative methods partnerships

Alternative Methods Partnerships

FDA works with a wide variety of domestic and global partners across government, industry, and academia to advance alternative methods. 

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

Featured Report (2021)

Read about FDA's cross-cutting work to spur the development of new regulatory approaches that can help improve predictivity.  (PDF, 1.9 MB)
Microphone on podium before webinar audience
Promoting cutting-edge technologies for disease modeling, efficacy, and safety

Developers: Tell us about your work

FDA gives developers the opportunity to present their new methods and methodologies exclusively to FDA scientists.

Related information

Emerging Sciences

FDA wants to understand how new areas of science will have an impact on our mission. Share your thoughts by submitting them to FDA's public idea portal.


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