NCHR’s Comment on Topics Discussed in the Advancing Premarket Safety Analytics Workshop 

NCHR had the opportunity to share our views with the Food and Drug Administration (FDA) about topics brought up in the Advancing Premarket Safety Analytics Workshop, including our support of the FDA Medical Queries as we believe it would better quantify adverse events. Additionally, we agree that the FDA should be transparent in providing their methods for the standard safety tables and figures via their integrated guide to the public and urge them to make these guidelines mandatory so that everyone is held to the same standard.

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