The FDA will now require only one clinical trial for most new drug approvals, a major shift from its decades-old two-study standard.
Agency leaders argue modern science makes a second confirmatory trial unnecessary, promising faster access to new medicines.
Critics warn this reduces evidence quality and increases uncertainty about drug effectiveness and safety for patients.
The policy contrasts with the FDA’s recent stricter demands for vaccines and gene therapies, highlighting inconsistent standards.
The change is the latest in a series of deregulatory moves by the current FDA leadership aimed at speeding drug development.
In a move that fundamentally reshapes the landscape of pharmaceutical regulation, the U.S. Food and Drug Administration announced it will abandon its long-standing requirement for two rigorous clinical trials to approve new drugs. On February 18, FDA Commissioner Dr. Marty Makary and a top deputy declared that a single trial will now be the agency’s “new default standard.” This seismic shift, aimed at accelerating drug availability, has ignited a fierce debate about scientific integrity, patient safety and the very role of a regulator historically tasked with ensuring that medicines are both effective and safe before they reach the public.
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