FDA Fast-Track Approval Trend: 70% of New Drugs Now Win Clearance With a Single Study

The FDA is greenlighting new drugs at an unprecedented pace, with 70% of recent approvals based on just one clinical study. This shift from the traditional two-study gold standard is reshaping drug development timelines and raising questions about evidence standards.

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This accelerated approval trend reflects the FDA's ongoing effort to get promising therapies to patients faster, but critics warn it may compromise rigor for speed. The pattern is particularly noticeable...