Janet Woodcock

Rule Changes

Retired from FDA in 2024 after 20+ years leading drug center

For 63 years, the Food and Drug Administration required drugmakers to prove their products worked in at least two rigorous clinical trials before Americans could take them. On February 18, 2026, Commissioner Marty Makary formally ended that standard, announcing that one trial will now be the "default position" for all new drugs—not just treatments for rare and fatal diseases, but medications for common conditions affecting millions of patients. In accompanying articles published in the New England Journal of Medicine and JAMA, Makary and Deputy Commissioner Vinay Prasad emphasized that the single-trial standard does not eliminate evidence requirements; instead, sponsors must provide "confirmative evidence" through mechanistic data, findings from related indications, animal models, real-world evidence, or data from drugs in the same class.

Updated Feb 20