One Pivotal Trial, the New Default Option for FDA Approval — Ending the Two-Trial Dogma

Vinay Prasad; Martin A. Makary

doi:10.1056/nejmsb2517623

February 18, 2026New England Journal of Medicine

One Pivotal Trial, the New Default Option for FDA Approval — Ending the Two-Trial Dogma

View at Publisher

Ask AI

Bookmark

Share

Key Points

To discuss the FDA's new default policy for drug approvals based on pivotal trial requirements.

Ask about this paper

Answers are grounded in this paper and cite their sources.

Implication

Policy change allows FDA approvals based on one pivotal trial plus confirmatory evidence, suggesting streamlined processes.

Abstract

This Sounding Board announces a new FDA policy that the default requirement for FDA approvals will be one robust pivotal trial plus confirmatory evidence, rather than two trials.

Discussion

No takes yet. Share an insight, caveat, or question.

Cite This Study

Prasad et al. (2026) studied this question.

synapsesocial.com/papers/6997b911baf9c852d8c25e17 https://doi.org/10.1056/nejmsb2517623

View at Publisher

Ask AI

Bookmark

Share

One Pivotal Trial, the New Default Option for FDA Approval — Ending the Two-Trial Dogma

Key Points

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

One Pivotal Trial, the New Default Option for FDA Approval — Ending the Two-Trial Dogma

Key Points

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Keep reading

Keep reading