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Pediatric Provision Moves OTC Monograph Reform To Subcommittee Vote

Executive Summary

An updated draft includes a provision requiring FDA to report annually to the Energy and Commerce Committee and to the Senate HELP Committee on the agency's evaluation of the cough and cold monograph to determine whether to impose more stringent limits on formulations allowed for use by children under age 6.

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OTC Monograph Reform Could ‘Unlock’ Innovations In Three Years

Following enactment of US OTC monograph reform, drug companies will unleash formulation innovations after keeping a lid on monograph R&D, CHPA anticipates. "A lot of companies have ideas like this they’ve kind of put in a drawer, that we think this is gonna unlock,” says David Spangler, an executive with the OTC trade group.

OTC Monograph Reform Could ‘Unlock’ Innovations In Three Years

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