FDA streamlines drug approval process with single-study requirement

thehindu.com [$]

The FDA will now require only one study for new drug approvals, aiming to speed up access to medicines. This change moves away from the decades-old standard of requiring at least two studies, reflecting advances in drug research precision and scientific understanding. The shift primarily impacts drugs for common diseases, as treatments for rare or fatal conditions have increasingly relied on single studies since the 1990s.


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FDA streamlines drug approval process with single-study requirement | News Minimalist