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FDA increasingly relies on single studies for drug approvals In 2024, the US FDA approved 69.4% of new drugs based on the results of a single study. An article published August 26 examined all FDA approvals from 2016 to 2024 and the 6,763 related studies. Over that period, the average number of studies supporting each approval fell from 3.41 to 1.39. The authors extracted from FDA packages the studies the agency directly relied on and those cited in the decision rationale. In February, FDA guidance proposed treating one pivotal study as the usual basis for approval. In the authors’ data, a single study became the most common approval basis already in 2017; in 2024, only 5.6% of approved drugs relied on three or more studies. The historical preference for two studies is tied to reproducibility: “Requiring at least two studies for approval reflects the core scientific principle of reproducibility.” The evidentiary package also includes trial design details—what treatment was compared to, how participants were allocated, and 🔗 Read original →