On Nov. 7, 2023, FDA issued final guidance that includes recommendations for reporting post-approval changes of some common changes to container closure system (CCS) components consisting of glass vials and stoppers for approved sterile drug products and biologics. The recommendations apply to approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs). Pathways available to application holders to obtain feedback from FDA are also presented. Risk-based tools for implementation of changes to CCSs consisting of glass vials and stoppers are provided. This guidance does not apply to CCS types other than glass vials and stoppers.
