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74. Presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements: guidance for industry

77. M7(R2) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk: guidance for industry

80. Institutional review board (IRB) review of individual patient expanded access submissions for investigational drugs and biological products: guidance for IRBs and clinical investigators