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The FDA plans to allow drug approvals based on a single clinical trial instead of the traditional two. Commissioner Marty Makary stated that this change aims to streamline the approval process while maintaining safety and efficacy standards. Some exceptions will still apply, where two trials may be required.
- FDA will now generally accept a single clinical trial for drug approval instead of the traditional two
- Two trials will still be required in certain (unspecified) cases
- Makary argues a well-designed, controlled single trial can match the statistical power of two trials
- Many drugmakers were already submitting only one pivotal trial, so the policy formalizes existing practice