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Proposed Rule Making More OTC Switches Likely In US Makes More Tools Necessary For Sponsors

Experts Discuss Proposed Rule’s Impact On Industry, Concerns For Digital Self-Selection Systems

 
• By Malcolm Spicer

OTC drug development and marketing consultants spoke with HBW Insight about FDA’s “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” proposed rule. In first of two articles, they discuss proposed rule’s likely impacts on industry and remaining concerns around incorporating extra-label information in drug labeling.

• Source: Shutterstock

A proposed rule to expand OTC switch opportunities in the US not only answered questions about using digital technology in labeling and for restricting product purchases but also increased costs for drug marketers and created business for consultants working with those firms.

OTC drug industry product development and marketing consultants spoke with HBW Insight about the Food and Drug Administration’s “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” proposed rule published on 27 June

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