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Codeine Concerns Cough Up FDA's OTC Monograph Problems

 
• By Malcolm Spicer

Pew Charitable Trusts joins CHPA, medical groups in urging Congress to authorize moving the US monograph system to an administrative process and to authorize a monograph user fee program.

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FDA recently ordered label changes for Rx codeine drugs but could do nothing immediately and directly to affect marketing of OTC monograph drugs containing the ingredient. This disconnect provides more evidence that FDA should be empowered with flexibility to address these kinds of situations, as it can for prescription drugs, consumer health industry stakeholders say.

Additionally, the Pew Charitable Trusts suggests the case is clearly made for establishing user fees to support FDA’s work in...

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