FDA considers requiring one clinical study as default for new drug and medical product approvals, aiming to speed development while weighing evidence limits

FDA plans to shift its default approach for drug and medical product approvals by requiring just one clinical study instead of the standard two before a product can be considered for approval. FDA Commissioner Marty Makary says the agency has become more flexible over time, and many drugmakers already submit a single pivotal trial. The rationale is that appropriately designed and controlled trials can achieve the statistical power that would otherwise require two studies. The change is framed as a way to speed development, but it also raises concerns about whether one trial could provide enough evidence on efficacy and safety in all cases, since FDA would still require two trials in some situations.