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BIO Comments on FDA Draft Guidance on Statistical Approaches to Evaluate Analytical Similarity

November 21, 2017

BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Statistical Approaches to Evaluate Analytical Similarity.

The draft guidance provides important advice on the evaluation of analytical similarity for sponsors of biological products licensed under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)). BIO provides general comments and suggested changes.


Download Full Comments Below
Final BIO Letter Statistical Approaches To Analytical Similarity 11-21-17
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