Janet Woodcock

Notable Quotes

"The scientific point is well taken that as we move toward greater understanding of biology and disease we don't need to do two trials all the time." — February 2026

from FDA shifts to single-study standard for drug approvals · Updated Feb 20

"It's not the cancers and the rare diseases that will be affected by this." — February 2026

from FDA shifts to single-study standard for drug approvals · Updated Feb 20

"Implementation will be everything." — February 2026

from FDA shifts to single-study standard for drug approvals · Updated Feb 20

Stories

FDA shifts to single-study standard for drug approvals

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

Janet Woodcock

Notable Quotes

Stories

FDA shifts to single-study standard for drug approvals

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