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BIO Comments on FDA Quality Metrics Reporting Program

June 22, 2022

On Wednesday, June 22nd, BIO submitted comments on the FDA’s Quality Metrics (QM) Reporting Program. In the comments submitted, BIO stated appreciation for FDA’s intent to support a general shift toward a risk-based approach to regulation by bolstering its quality surveillance activities. However, BIO expressed the need for clarification around the program’s implementation to ensure it meets the Agency’s objectives without resulting in unintended consequences for both sponsors and regulators. In general, BIO pointed out significant variability in how metrics would be identified, defined, and reported. In addition to challenges posed by this variability, it is unclear how such data would be utilized by FDA. Thus, required reporting of lower-level metrics without contextual information associated with the data or trends could negatively impact sponsor operations and increase the potential for regulatory misinterpretation.

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