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Facilitating More OTC Switches In US Graduates To Regulatory Plan On FDA’s Unified Agenda

Fall 2021 Update Also Includes OTC Hearing Aid, Drug Co-Packaging, IND Exemption Timelines

Executive Summary

For first time rules for novel switches and OTC hearings aids are parts of “significant regulatory actions” in agency’s plans. Information is added in Unified Agenda items explaining likely benefits and costs from the changes.

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