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The FAIR Act establishes a reciprocal approval mechanism allowing the FDA to grant marketing approval for drugs and biologics already approved by trusted international regulatory authorities (European Medicines Agency, UK MHRA, Health Canada, and others designated by HHS) for immediately life-threatening diseases. The bill also permits clinical trials in the U.S. to proceed if authorized by these same trusted authorities, with FDA decisions required within 30 days. The FDA retains authority to withdraw approval if new evidence demonstrates unreasonable safety risks or if the foreign regulator rescinds approval, and must report to Congress within 5 years on the program's effectiveness and impact on patient safety.
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