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
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.