The Food and Drug Administration (FDA) will now require only one successful clinical trial, rather than two, to approve new drugs, a shift announced in the New England Journal of Medicine on February 19, 2026. The change, detailed in Volume 394, Issue 8, aims to accelerate the drug approval process.
The decision to reduce the study requirement comes as the FDA seeks to streamline its procedures, according to reports from the American Journal of Managed Care and Pharmaceutical Executive. Previously, the agency generally required two independent, well-controlled studies demonstrating substantial evidence of efficacy to grant approval for new medications.
Pharmaceutical Commerce reported that the FDA’s move toward a single-trial requirement represents a significant policy change. The agency has not specified which types of drugs will be most affected by this new policy, but the shift is expected to expedite the availability of new treatments for a range of conditions.
The change was initially signaled in June 2025, according to the New England Journal of Medicine, but the formal announcement detailing the implementation of the single-trial standard was published this week. The FDA has yet to release detailed guidance on how the new policy will be applied in practice, including criteria for determining the acceptability of a single trial’s data.
The FDA has not yet responded to requests for comment regarding potential impacts on patient safety or the rigor of the drug approval process. Further clarification from the agency is expected in the coming weeks.
