FDA to Drop Two-Study Requirement for New Drug Approvals

The move aims to speed up access to new medications, but raises questions about implementation.

Published on Feb. 23, 2026

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The Food and Drug Administration (FDA) plans to drop its longstanding requirement of two rigorous studies to approve new drugs, a change that officials say will accelerate the availability of certain medical products. Going forward, the FDA's 'default position' will be to require only one study for new drugs and other novel health products, according to FDA Commissioner Dr. Marty Makary and a top deputy, Dr. Vinay Prasad.

Why it matters

The announcement reflects the FDA's ongoing efforts under the Trump administration to shorten review times and reduce bureaucracy, though the agency has taken a more restrictive approach with other products like vaccines. The shift could lead to a 'surge in drug development,' but raises questions about whether it will be applied consistently across different types of treatments.

The details

The two-study standard for drug approvals has been in place since the 1960s, with the second study meant to confirm the first trial's results. However, the FDA has increasingly accepted single studies, especially for rare or fatal diseases. Now, the new policy will mainly impact drugs for common conditions that previously required two trials.

  • The FDA's new one-study policy will take effect immediately.
  • Over the last five years, roughly 60% of first-of-a-kind drugs were approved based on a single study.

The players

Dr. Marty Makary

The current FDA Commissioner who has launched a series of directives to shorten FDA reviews.

Dr. Vinay Prasad

A top deputy to Makary at the FDA who co-authored the announcement about dropping the two-study requirement.

Dr. Janet Woodcock

The former longtime director of the FDA's drug center, who says the change makes sense as drug research has become more precise.

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What they’re saying

“In this setting, overreliance on two trials no longer makes sense. In 2026 there are powerful alternative ways to feel assured that our products help people live longer or better than requiring manufacturers to test them yet again.”

— Dr. Marty Makary, FDA Commissioner (New England Journal of Medicine)

“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.”

— Dr. Janet Woodcock, Former FDA Drug Center Director (Associated Press)

What’s next

The FDA's new one-study policy for drug approvals will take effect immediately, though it remains to be seen how the agency will apply it consistently across different types of treatments.

The takeaway

The FDA's decision to drop its longstanding two-study requirement for new drug approvals reflects an effort to accelerate the availability of certain medical products, but raises concerns about whether the agency will apply the policy evenly and maintain appropriate scientific standards.