Source: STAT 10
The U.S. Food and Drug Administration is considering a major change to how new drugs and medical products are evaluated for approval by shifting toward requiring only a single pivotal clinical trial instead of the traditional two. Historically, regulators have asked for two well-controlled trials to demonstrate safety and effectiveness, but FDA Commissioner Marty Makary told STAT that one well-designed study can often provide the same statistical strength as two, and many companies already rely on a single trial in practice.
Under the proposal, the default expectation for most applications would become one trial, though the agency would still require two studies in certain cases. This shift is intended to streamline approvals and potentially speed product development and patient access, though it raises questions about evidence standards and regulatory rigor. Final policies could take several months to complete as the FDA updates its guidance.
Read the full story HERE: https://www.statnews.com/2025/12/04/fda-considers-single-clinical-trial-for-new-product-approvals/