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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

 
• By Malcolm Spicer

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.

• Source: Alamy

The US Food and Drug Administration once again includes in its regulatory agenda update a timeline for publishing a proposed rule to facilitate novel Rx-to-OTC switches. But for the first time the agency includes the change as part of “significant regulatory actions” in its plans.

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