US EditionFDA 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.
68 Articles
68 Articles
FDA to stop requiring 2 studies before approval of new drugs
WASHINGTON — The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to secure approval for new drugs, the latest change from Trump administration officials vowing to speed up the availability of certain medical…
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Mittelstand Cafend.DerTag / nd.DieWoche [Newsroom]Berlin (ots) - No longer two studies, but only one should soon be enough to obtain approval for a new drug in the USA. Still there are only statements in the medical specialized press, but it seems as if should be ... Continue reading here...Original content of: nd.DerTag / nd.DieWoche, transmitted by news aktuell
FDA to Drop Two-Study Requirement for New Drug Approvals
(MedPage Today) -- The FDA plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest change from Trump administration officials vowing to speed up the availability of certain medical products...
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