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‘Fail First’ Requirement In ACNU Proposal Prompts Adverse Reactions Across US Drug Industry

Executive Summary

PhRMA captures tone of its comments saying “proposed rule might play an important role” in making more drugs available OTC. AAM also references gauntlet, saying proposed pathway “would, in theory, broaden the types of nonprescription drugs available to consumers.” CHPA discusses same concerns as well as additional questions for FDA.

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