Efforts to Decrease Animal Testing and Usher in New Technologies
Efforts to Decrease Animal Testing and Usher in New Technologies
Publish Date: 2026-03-24 13:49:00
Source Domain: www.morganlewis.com
LawFlash
March 24, 2026
Following its release of a roadmap for phasing out animal testing, on March 18, 2026 FDA released a draft guidance on General Considerations for the Use of New Approach Methodologies in Drug Development. This guidance signals a willingness by FDA to consider the use of new technologies for drug development. Technology developers should pay special attention to this evolving and growing area of FDA opportunity and regulation as it creates openings for new entrants into the drug development ecosystem as well as new requirements.
FDA’s draft guidance comes at a time when drug development in the United States is approaching a crossroads. Due to regulatory challenges, the time it takes to initiate US clinical trials, and the overall cost, companies are looking to other countries for their initial development efforts, such as China and Australia, where early-stage development may proceed at a faster pace.
Recognizing this, FDA has begun taking steps to facilitate and encourage domestic drug development activities, including proposals for the next reauthorization of the Prescription Drug User Fee Act to include both carrots and sticks to promote the conduct of Phase 1 clinical trials in the United States.
Further, FDA Commissioner Marty Makary recently articulated the need for FDA to shorten the time it takes for sponsors to move into Phase 1 trials, including through reforms to Institutional Review Board requirements. Accordingly, FDA is likely to be receptive to industry innovation that makes US-based drug development faster or less expensive.
FDA’S NAM DRAFT GUIDANCE
Against this backdrop, FDA’s draft guidance provides “a validation framework for new approach methodologies (NAMs) used in drug development to improve predictive toxicology in humans and move away from reliance on animal testing.” NAMs include a variety of testing methodologies, including in-vitro human-derived…
