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20 Although the FDA extended its final enforcement deadline for enhanced drug distribution requirements in November of 2023 for a one-year stabilization period, 21 the agency will undoubtedly continue to be focused on ensuring compliance with track and trace requirements that have already come into effect, in addition to continued progress toward full implementation

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In their briefing documents, agency staff concluded that the available human evidence was too thin to establish adequate safety, effectiveness, chemical characterization, and quality control