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Exclusivity Provision Surfaces In OTC Monograph Bill

 
• By Malcolm Spicer

The House Health subcommittee asks whether allowing manufacturers' periods of US market exclusivity for some approved OTC monograph proposals is needed, or would be fair to consumers.

Capitol House

Members of the House Energy and Commerce Committee are interested in allowing manufacturers periods of market exclusivity for some OTC monograph products as part of legislation to streamline the FDA system and establish a user fee program to support the agency's work in the area.

That was one of the take-aways from the Sept. 13 House Energy and Commerce Health Subcommittee hearing on OTC monograph...

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