US EditionFDA will drop two-study requirement for new drug approvals, aiming to speed access
The FDA will require only one adequate study for new drug approvals, reflecting advances in research and aiming to speed patient access; 60% of first-of-a-kind drugs already follow this.
- 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.
- The decision sits alongside recent restrictive FDA moves on vaccines and gene therapies: last week, the FDA's vaccine division, headed by Dr. Vinay Prasad, refused Moderna's application, then agreed Wednesday to review it after Moderna pledged another study in older people.
32 Articles
32 Articles
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FDA to drop two-study requirement for new drug approvals, speed access
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