FDA Leaders Propose New “Plausible Mechanism Pathway” for Development and Approval of Drugs and Biologics

The Food and Drug Administration (FDA) has issued a statement, published electronically in the New England Journal of Medicine (NEJM) on November 12, 2025, proposing a new process for obtaining marketing authorization for drugs and biological products where a randomized trial is not feasible and the focus is on treatment of single patients or very small patient populations. The article, which was authored by Vinay Prasad (Director of FDA’s Center for Biologics Evaluation and Research) and Martin…
By: King & Spalding