FDA to Drop Two-Study Requirement for New Drug Approvals

Move aims to speed up availability of certain medical products

Published on Feb. 23, 2026

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The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals, the latest change from Trump administration officials vowing to speed up the availability of certain medical products. Going forward, the FDA's 'default position' will be to require one study for new drugs and other novel health products.

Why it matters

The change reflects the FDA's decades-long move toward relying on one trial, combined with supporting evidence, for various life-threatening diseases, including cancer. However, the new policy will mainly impact drugs for common diseases that previously weren't eligible for reduced testing standards.

The details

FDA Commissioner Dr. Marty Makary and a top deputy, Dr. Vinay Prasad, wrote in a New England Journal of Medicine piece that dropping the two-trial requirement reflects modern advances that have made drug research 'increasingly precise and scientific.' They predict the shift will lead to 'a surge in drug development.' The two-study standard for drugs dates to the early 1960s, but the FDA has increasingly accepted single studies for the approval of treatments for rare or fatal diseases.

  • The FDA announced the change on February 18, 2026.

The players

Dr. Marty Makary

Commissioner of the Food and Drug Administration.

Dr. Vinay Prasad

A top deputy at the Food and Drug Administration.

Dr. Janet Woodcock

The FDA's former drug director who led the FDA's drug center for about 20 years before retiring in 2024.

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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 Director (AP)

What’s next

The FDA's implementation of the new one-study requirement will be closely watched by the drug industry, which is already 'baffled' by the agency's approach to promising experimental therapies.

The takeaway

The FDA's decision to drop the two-study requirement for new drug approvals reflects the agency's ongoing efforts to accelerate the availability of certain medical products, though the impact will be most significant for common disease treatments rather than rare or fatal conditions.