Foley & Lardner·FDA / LIFE SCIENCES REGULATORY
FDA Direct Final Rule Recasts 'Nonclinical' Terminology for NAMs
FDA's September 2026 direct final rule replaces 'animal' and 'preclinical' study references with 'nonclinical' studies, comments close December 7, 2026, and it takes effect February 4, 2027 absent significant adverse comments.
fda-direct-final-rulenew-approach-methodologiesnonclinical-studiesanimal-testing-reductiondrug-developmentregulatory-submissions
Read the original firm alert → Thursday, October 8, 2026