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AdvaMed Asks For Pre-Review Option For Patient-Reported Outcome Tools

This article was originally published in The Gray Sheet

Executive Summary

AdvaMed is urging FDA to pre-review sponsors' strategies for using patient-reported data to support product labeling claims before a clinical trial is initiated

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Regulatory News In Brief

FDA may publicize inspection reports: FDA is seeking input on whether it should publicly disclose key findings from inspection reports. Currently, Form 483 reports, which list observations made during an inspection of a firm, are not made public. Freedom of Information Act requests for the reports can take a long time because of the need to redact confidential trade secret information, FDA notes. In a Nov. 21 post on its 1Transparency Blog, FDA asks whether the reports should be redesigned to separate out a summary or key findings page that could quickly be made publicly available. Three commenters on the post supported the concept

Regulatory News In Brief

FDA may publicize inspection reports: FDA is seeking input on whether it should publicly disclose key findings from inspection reports. Currently, Form 483 reports, which list observations made during an inspection of a firm, are not made public. Freedom of Information Act requests for the reports can take a long time because of the need to redact confidential trade secret information, FDA notes. In a Nov. 21 post on its 1Transparency Blog, FDA asks whether the reports should be redesigned to separate out a summary or key findings page that could quickly be made publicly available. Three commenters on the post supported the concept

FDA Offers Advice On Using Patient Reports For Trial Endpoints

FDA will support the use of patient-reported data in clinical trials as long as the sponsor makes the measurement tools as robust and meaningful as possible, the agency indicates in a Feb. 3 draft guidance document to industry

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