FDA will drop two-study requirement for new drug approvals, aiming to speed access
Medical Xpress
February 19, 2026
AI-Generated Deep Dive Summary
The FDA is set to eliminate its long-standing requirement that new drugs undergo two rigorous studies to gain approval, marking a significant shift aimed at accelerating access to medical treatments under the Trump administration. This move reflects ongoing efforts by agency officials to streamline processes and make certain medical products available more quickly.
Historically, the two-study standard was seen as a stringent measure to ensure drug safety and efficacy. However, this approach has been criticized for causing delays in approvals, which can lead to higher costs for patients and potential harm from delayed treatments. The FDA's decision to drop this requirement signals a pivot toward alternative methods of evaluation, such as using real-world evidence or single pivotal studies that meet specific criteria.
While the change is expected to speed up drug approvals, it raises questions about how safety and efficacy will be assessed in the absence of two rigorous studies. Critics argue that this could lead to risks if not implemented carefully, but supporters believe it will foster innovation and reduce barriers for patients needing timely access to life-saving medications. This shift may also set a precedent globally, influencing how regulatory agencies approach drug approval processes.
For readers interested in health, this change matters because it directly impacts the availability of new treatments. Faster approvals could mean earlier access to potentially groundbreaking therapies, though concerns about safety remain. The FDA's decision balances the need for innovation with the critical importance of maintaining high standards for patient safety, a delicate line that will be closely watched by stakeholders across the medical and regulatory landscape.
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Originally published on Medical Xpress on 2/19/2026