Placeholder Banner

BIO Comments on FDA Draft Guidance on Statistical Approaches to Evaluate Analytical Similarity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BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Statistical Approaches to Evaluate Analytical Similarity.

The draft guidance provides important advice on the evaluation of analytical similarity for sponsors of biological products licensed under section 351(k) of the Public Health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
Read full comment letter below
Discover More
We the undersigned Governors would like to draw your attention to an important issue facing U.S. agriculture. Farmer access to new biotechnologies, such as gene editing, is critical to maintaining the security and stability of the rural economy and…
We write as a coalition of advocates for the startup ecosystem to voice our strong support for the IGNITE American Innovation Act, legislation to support startups through the economic crisis by allowing companies to monetize tax assets generated…