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BIO Comments on FDA Draft Guidance on ICH E19 Optimization of Safety Data Collection

September 27, 2019

BIO submitted comments to the Food and Drug Administration (FDA) on E19 Optimisation of Safety Data Collection; International Council for Harmonisation.

BIO welcomes this document on the optimization of safety data collection and supports the goal of internationally harmonized guidance on when it’s appropriate to use a selective approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented. BIO provides general and detailed comments for FDA’s consideration.

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