BIO Comments on FDA Draft Guidance on Statistical Approaches to Evaluate Analytical Similarity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BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Statistical Approaches to Evaluate Analytical Similarity.
The draft guidance provides important advice on the evaluation of analytical similarity for sponsors of biological products licensed under section 351(k) of the Public Health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
Re: Docket No. CDC-2025-0454; Advisory Committee on Immunization Practices (ACIP)The Biotechnology Innovation Organization (BIO) is appreciative of the opportunity to provide comments to the Advisory Committee on Immunization Practices (ACIP) in…
Dear Majority Leader Thune, Minority Leader Schumer, Speaker Johnson, and Minority Leader Jeffries:The Council of State Bioscience Associations (CSBA) is a coalition of independent state and territory based non-profit trade associations, each of…
BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Statistical Approaches to Evaluate Analytical Similarity.
The draft guidance provides important advice on the evaluation of analytical similarity for sponsors of biological products licensed under section 351(k) of the Public Health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.