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CMC: BIO Submits Comments on FDA Draft Guidance Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information

Re: Docket No. FDA-2016-D-0973: Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information

Dear Sir/Madam:

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information” (Draft Guidance). 

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.

We find this Draft Guidance to be thorough and well-considered. It takes into account several approaches to utilizing change protocols for postapproval changes. It would be helpful for the Draft Guidance to state that the content requirements should follow the current common technical document (CTD) format. Finally, it will be important that this Guidance is aligned with the final ICH Q12 guideline once complete. To this end, BIO notes that continuity and consistency of terms across various guidances and guidelines will be necessary in order to ensure clarity for both Sponsors and Regulatory Authorities.

We provide additional specific, detailed comments to improve the clarity of the Draft Guidance in the following chart. We would be pleased to provide further input or clarification of our comments, as needed.