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FDA will drop two-study requirement for new drug approvals, aiming to speed access
The FDA will adopt a one-study default to approve new drugs, reflecting modern science and laws for serious conditions; about 60% of first-of-a-kind drugs already used this, officials said.
- On Wednesday, FDA Commissioner Dr. Marty Makary and Deputy Dr. Vinay Prasad wrote in a New England Journal of Medicine that the FDA's default will be to require one study for new drugs, citing modern advances.
- The two-study rule dates to the early 1960s when U.S. Congress required FDA historical reviewers to confirm reproducibility of trial results through adequate and well-controlled investigations.
- Dr. Janet Woodcock said the change makes sense and reflects a long shift, with roughly 60% of first‑of‑a‑kind drug approvals in the last five years relying on a single study.
- FDA officials predicted the move would spur a surge in drug development, while Dr. Janet Woodcock said the policy will mainly affect common‑disease drug approvals that lacked prior reduced testing eligibility.
39 Articles
39 Articles
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