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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.
The FDA is exploring the use of AI, specifically through discussions with OpenAI, to expedite the drug approval process. This initiative, led by the FDA's first AI officer, aims to modernize regulatory reviews, although concerns about AI reliability and proper data training persist.