BIO Comments on FDA Draft Guidance on Statistical Approaches to Evaluate Analytical Similarity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BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Statistical Approaches to Evaluate Analytical Similarity.
The draft guidance provides important advice on the evaluation of analytical similarity for sponsors of biological products licensed under section 351(k) of the Public Health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
Dear Mr. Thune, Mr. Schumer, Mr. Johnson, and Mr. Jeffries:As President and CEO of the Biotechnology Innovation Organization (BIO), as a father and entrepreneur whose family is here today because of biotech innovation, and on behalf of the more than…
BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Statistical Approaches to Evaluate Analytical Similarity.
The draft guidance provides important advice on the evaluation of analytical similarity for sponsors of biological products licensed under section 351(k) of the Public Health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.