BIO Comments on FDA Draft Guidance on CMC Postapproval Manufacturing Changes for Specified Biological Products
BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports.
BIO appreciates the effort to categorize listed annual reportable changes for biologics based on the associated commensurate risk, along with the annual reportable manufacturing type examples in the draft guidance.
However, BIO recommends the final guidance include examples of situations where annual reportable listed changes may be better categorized by applicants as a supplement based on certain specific circumstances. BIO asks for additional clarifications to the draft guidance, including whether this draft guidance will be aligned with the final ICH Q12 guideline.