In the United States, the Food and Drug Administration (FDA) announced a significant change in its drug approval process that will impact the requirements for new drug submissions. This decision was made public in a New England Journal of Medicine article published by FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad. The FDA will now require only one rigorous study for new drugs and other novel health products, moving away from the decades-old standard that mandated two comprehensive studies for approval. This shift reflects modern advances in drug research and aims to streamline the approval process, which has historically been burdened by bureaucracy. Dr. Makary and Dr. Prasad argue that the reliance on two trials is outdated in the context of modern scientific understanding. They believe that advancements in drug research have allowed for greater precision, thus making the previous requirement less relevant. Their announcement aligns with ongoing changes within the FDA that aim to expedite the development and availability of medical products, particularly for common diseases. Consequently, the shift in policy is expected to create a surge in drug development. Former FDA drug director Dr. Janet Woodcock supports this change, noting that the FDA has gradually started to accept single studies for life-threatening diseases, including cancer, over the years. The historical context shows that this two-study requirement dates back to the early 1960s, when Congress mandated that the FDA review data from adequately controlled studies before clearing medications. Over the years, especially from the 1990s onward, the FDA has increasingly accepted single studies for rare diseases, recognizing the challenges associated with testing in larger populations. While the change signals a move toward more efficient drug approval processes, it also contrasts sharply with the FDA's recent actions concerning vaccines and gene therapies. Recent refusals to accept applications for certain vaccines indicate a stricter approach when it comes to those particular products. The FDA’s new policy, while promising to hasten drug development, has raised questions about consistency and clarity in the agency's regulatory framework.