The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals.
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Marty Makary, commissioner of the Food and Drug Administration speaks at an event on addiction recovery in the Oval Office of the White House, Thursday, Jan. 29, 2026, in Washington, as Attorney General Pam Bondi and Interior Secretary Doug Burgum listen. plans to drop its longtime standard of requiring two rigorous studies to win approval of new drugs, 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, FDA CommissionerSince arriving at the agency last April, Makary has launched a series of directives that he says will shorten FDA reviews, including mandating the use of artificial intelligence by staffers and offeringIt contrasts with the FDA’s more restrictive approach to other products, including vaccines. In their piece published Wednesday, Makary and Prasad state that dropping the two-trial requirement reflects modern advances that have made drug research “increasingly precise and scientific.” “In this setting, overreliance on two trials no longer makes sense,” they write. “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. Janet Woodcock, the FDA's former drug director, 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, “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,” said Woodcock, who led the FDA's drug center for more than 20 years before retiring in 2024. The two-study standard for drugs dates to the early 1960s, when Congress passed a law requiring the FDA to review data from “adequate and well-controlled investigations,” before clearing new medications. For decades, the agency interpreted that requirement as meaning at least two studies, preferably with a large number of patients and significant follow-up time. The reason for requiring the second study was to confirm that the first trial's results weren’t a fluke and could be reproduced. But beginning in the 1990s, the FDA increasingly began accepting single studies for the approval of treatments for rare or fatal diseases that companies often struggle to test in large numbers of patients. Over the last five years, roughly 60% of first-of-a-kind drugs approved each year have been cleared based on a single study. The shift reflects laws passed by Congress that directed regulators to be more flexible when reviewing drugs for serious or hard-to-treat conditions. Woodcock said the new policy announced Wednesday will mainly impact drugs for common diseases that previously weren't eligible for reduced testing standards. “It’s not the cancers and the rare diseases that will be affected by this,” she noted. “The agency has been approving those on a single trial already.” The latest approach from FDA leadership contrasts with the agency's recent actions on vaccines, gene therapies and other treatments.Moderna’s application for a new mRNA flu shot, saying its clinical trial was insufficient. Then on Wednesday the agencySeparately, Prasad has rejected a string of experimental gene therapies and biotech drugs, citing the need for additional studies or more definitive evidence. The trend has weighed on the stocks of many biotech companies and clashed with Makary's public statements promoting the speed and flexibility of the FDA's reviews. Woodcock said the drug industry will have to wait and see whether the FDA's approach to promising experimental therapies changes. “Implementation will be everything,” she said. “Since the agency's approach is unclear, and the industry is already baffled, I don't think this adds any illumination.”The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content. Copyright 2026 The Associated Press. All rights reserved. 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FDA will drop two-study requirement for new drug approvals, aiming to speed accessThe Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals.
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FDA will drop two-study requirement for new drug approvals, aiming to speed accessWASHINGTON (AP) — The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval of new drugs, the
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FDA drug approvals: Makary and Prasad say one study will be enoughThe Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals. The change announced Wednesday is the latest move by Trump administration officials vowing to speed up the availability of medical products.
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FDA will drop two-study requirement for new drug approvals, aiming to speed accessThe Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals.
Read more »