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US FDA’s Proposed ACNU OTC ‘Failure’ Reports Requirement: Asking Too Much, Or Too Little?

Executive Summary

Periodic summaries FDA is considering are “most effective method to track and report relevant concerns,” but “failure” as outlined in proposed rule is too broad, says CHPA. Digital care delivery firm Amwell says FDA should ask ACNU OTC marketers for some individual adverse event reports in addition to summaries.

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