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Information procedures, review times and web sites aired at recent update meeting in Washington

This article was originally published in Clinica

Executive Summary

The FDA is looking at how to interpret a clause in the FDA Modernisation Act, intended to keep overzealous product reviewers in check. However, it is not clear whether or not the agency will produce an actual guidance document on the subject, Susan Alpert, director of the Office of Device Evaluation said last week.

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