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OTC Monograph Process Not Broken But Needs Repair – CHPA

This article was originally published in The Tan Sheet

Executive Summary

The trade group’s presentation at FDA’s upcoming public hearing will underscore the monograph process’s value in making more OTC drugs available but also ask why the process is not working as intended. Scheduled speakers also include Peter Barton Hutt, the former FDA chief counsel recognized as the architect of the monograph system, and self-care medication expert Bill Soller.

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