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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

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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