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Patient Data In Drug Reviews Would Be Encouraged In Proposed Amendment To User Fee Bill

 
• By Brenda Sandburg

Rep. Matsui withdrew amendment on FDA’s use of patient experience data during health subcommittee markup of user fee reauthorization legislation, but it may be considered in full committee markup following agency input. Chair Eshoo says the provision specifying contrast agents must be regulated as drugs needs to be reworked to include ophthalmic products.

Patient experience
FDA may have to disclose how it uses patient experience data in drug reviews • Source: Shutterstock

A bill requiring the US Food and Drug Administration to describe its consideration of patient experience data in assessing a drug application has a chance of being included in legislation to renew the agency's user fee programs.

Rep. Doris Matsui, D-Calif., withdrew a proposed amendment to include the measure during subcommittee markup of the user fee legislation

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