FDA to Drop Two-Study Requirement for New Drug Approvals

Move aims to speed up access to new medications, but raises concerns about oversight

Published on Feb. 23, 2026

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The Food and Drug Administration (FDA) plans to drop its longtime standard of requiring two rigorous studies to win approval of new drugs, a move 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 change reflects the FDA's efforts to shorten review times and increase the pace of drug development, but it also raises concerns about whether adequate oversight and safety measures will be maintained. The two-study requirement had been in place since the 1960s to help ensure that initial trial results were not a fluke, and the shift could impact drugs for more common diseases that previously required more extensive testing.

The details

The FDA officials stated that dropping the two-trial requirement reflects modern advances that have made drug research 'increasingly precise and scientific.' They predicted the shift would lead to 'a surge in drug development.' However, the move contrasts with the FDA's more restrictive approach to other products, including vaccines, where the agency has recently rejected applications due to insufficient clinical trial data.

  • The FDA's new policy will take effect immediately.
  • The two-study standard for drugs has been in place since the early 1960s.

The players

Dr. Marty Makary

The current FDA Commissioner who has launched a series of directives aimed at shortening FDA reviews and accelerating the availability of new medicines.

Dr. Vinay Prasad

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

Dr. Janet Woodcock

The former director of the FDA's drug center for over 20 years, who said the change makes sense and reflects the FDA's decades-long move toward 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 new FDA policy will take effect immediately, and the agency expects it will lead to a surge in drug development. However, it remains to be seen how the FDA will implement the change and whether it will apply the same flexibility to other types of medical products, such as vaccines and gene therapies.

The takeaway

The FDA's decision to drop the two-study requirement for new drug approvals is a significant shift that aims to accelerate the availability of new medications. While the agency cites advances in drug research, the move raises concerns about whether adequate safety and oversight measures will be maintained, especially for drugs targeting more common diseases that previously required more extensive testing.