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Monograph Reform Legislation In Play As FDA, OTC Industry Get Real On Changes

 
• By Malcolm Spicer

FDA and CHPA preparing for changes to monograph procedures the agency and industry negotiated, including a user fee program, and are included in legislation passed by House and introduced in Senate. But neither the agency nor the trade group expects to be entirely ready before the legislation passes, whenever that might be.

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Overhauling the US Food and Drug Administration's OTC drug monograph program depends on Congress passing legislation, something agency officials and industry stakeholders are confident will come but aren't predicting when.

The FDA and the Consumer Healthcare Products Association are preparing for changes to monograph procedures that the agency and industry stakeholders negotiated, including a user fee program, and that are included in legislation passed by the House and introduced in the Senate

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