28-30 March 2023
The U.S. Food and Drug Administration (FDA) released the final guidance on Comparability Protocols (CPs) for postapproval CMC changes. The revised guidance follows the draft version issued in April 2016.
Among the changes are the following:
The CP may be submitted as part of the original application or in a prior approval supplement (PAS).
Additionally, the guidance provides a "Questions and Answers" section on CPs in the Appendix, which covers changes to
More information is available in FDA´s Guidance for Industry Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.