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Pediatric Provision Moves OTC Monograph Reform To Subcommittee Vote

 
• By Malcolm Spicer

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.

Capitol House

The House Health Subcommittee scheduled a markup of draft legislation to accelerate and pay for FDA's process for adding OTC monograph drug ingredients after a provision was added requiring the agency to evaluate pediatric cough/cold formulations.

The subcommittee shows some urgency for sending the legislation to the Energy and Commerce Committee by marking up the draft...

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