FDA Drops Two-Study Requirement for New Drug Approvals

The agency's 'default position' will now be to require only one study for new drugs and other novel health products.

Feb. 22, 2026 at 11:30am

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The Food and Drug Administration (FDA) has announced that it will drop its longstanding requirement of two rigorous studies to approve new drugs. 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

This change reflects the FDA's move towards greater flexibility and a faster approval process for new drugs, with the goal of accelerating the availability of certain medical products to Americans. However, the decision contrasts with the FDA's more restrictive approach to other products, such as vaccines, raising questions about the agency's overall strategy.

The details

The two-study standard for drug approvals has been in place since the early 1960s, but the FDA has been increasingly accepting single studies for the approval of treatments for rare or fatal diseases in recent years. The new policy announced by Makary and Prasad will mainly impact drugs for common diseases that previously weren't eligible for reduced testing standards.

  • The FDA's new policy was announced on February 22, 2026.

The players

Dr. Marty Makary

The FDA Commissioner who announced the new policy.

Dr. Vinay Prasad

A top deputy to Dr. Makary who co-authored the announcement.

Dr. Janet Woodcock

The former director of the FDA's drug center, who said the change makes sense and reflects the agency's decades-long move towards relying on one trial, combined with supporting evidence, for various life-threatening diseases.

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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 policy is expected to lead to a surge in drug development, as the agency moves towards a more flexible and accelerated approval process for new medications.

The takeaway

The FDA's decision to drop its two-study requirement for new drug approvals represents a significant shift in the agency's approach, prioritizing speed and flexibility over the traditional, more rigorous testing standards. While this change may accelerate the availability of new drugs, it also raises concerns about the potential impact on public health and safety, particularly in light of the agency's more restrictive stance on other medical products like vaccines.