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# FDA Easing Drug Approval Standards: Column
- URL: https://www.fdaweb.com/fda-easing-drug-approval-standards-column/
- Published: 2025-12-17T12:00:00.000Z
- Updated: 2026-09-14T15:29:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160406

FDA's recent plans to further reduce clinical trial requirements for drugs are raising concerns in some outside experts, according to an online *Medshadow* column. The column says the agency action, which was confirmed by commissioner **Marty Makary** in a *Stat* interview, could allow drug companies to pursue agency approval with just one pivotal trial.

Asked about the change, Yale School of Medicine professor **Joseph Ross** said, “For the most part, it’s not clear to me why the announcement is coming out the way it is coming out. FDA has a very clear and structured process for proposing new policy that involves establishing draft guidance, working with experts, and putting it out for public comment before finalizing that guidance. This idea of just telling everybody that the standards have changed is not the way policy is typically made.”

The column traces a decades-long FDA trend to loosen the drug approval requirements in hopes of bringing new treatments to patients faster. “FDA has been drifting in this direction for quite a long time now,” says Stanford University health policy researcher **Robert Kaplan**.

The post says that if fewer trials are needed, the safety and efficacy of new drugs increasingly will hinge on the strength of the confirmatory evidence supporting them. It notes that in a 2025 study, Ross found that fewer than 20% of new drugs approved on a single pivotal trial from 2015 to 2023 were supported by any confirmatory evidence of effectiveness. “That means 80% of the time we had no idea how the approval based on a single trial was being made,” he said.

The article also makes the point that the move to lower approval standards for drugs is coming at a time when FDA is raising the approval standards for vaccines.