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.
On Tuesday, January 3rd, BIO submitted comments in response to the Food and Drug Administration’s (FDA) recent draft guidance containing recommendations for sponsors on monitoring growth and evaluating pubertal development in clinical trials which…
BIO and its members appreciate the opportunity to work with FDA to develop and align on approaches that are robust, practical, and expedite patient focused drug development. To further enhance the Guidance, we believe that a few areas would benefit…
On Wednesday, September 28th, BIO submitted comments to the Food & Drug Administration on the ICH Q2(R2) Guideline: Validation of Analytical Procedures and the ICH Q14 Guideline: Analytical Procedure Development. In addition to a number of…
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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.