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OTC Monograph Process Not Broken But Needs Repair – CHPA

 
• By Malcolm Spicer

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.

Consumer Healthcare Products Association executives will tell FDA that the OTC monograph system is not broken but needs improvement, in their presentation to the agency’s upcoming public hearing on the system.

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