In a move that is already sending ripples through the pharmaceutical world, the Food and Drug Administration under the Trump administration has announced a major shift in how new drugs will be approved. The change could dramatically speed up the process of getting treatments into the hands of American patients.
For decades, the FDA typically required two large, well-controlled clinical trials before approving a new drug. That long-standing standard is now being reconsidered.
According to a new policy outlined by FDA Commissioner Dr. Marty Makary and top deputy Dr. Vinay Prasad in the New England Journal of Medicine, the agency’s “default position” will now require just one study for new drugs and other novel medical products.
The shift marks one of the most significant regulatory changes in years. Makary and his team argue that modern science has evolved to the point where duplicating studies is often unnecessary.
“In this setting, overreliance on two trials no longer makes sense,” they wrote. “In 2026 there are powerful alternative ways to feel assured that our products help people live longer or better than requiring manufacturers to test them yet again.”
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