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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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
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