Comment from Association for Accessible Medicines (AAM)
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Summary: The Association for Accessible Medicines (AAM) supports the FDA's risk-based approach to CMC changes but argues that the current SUPAC guidances are a confusing patchwork that needs consolidation into a single, structured framework. They recommend harmonizing these guidances with international standards (like ICH Q12), updating outdated numerical limits to allow for more flexibility, and expanding coverage to include complex products and modern manufacturing technologies.
FDA,
Please find attached comments from the Association for Accessible Medicines (AAM)
regarding Docket No. FDA-2026-N-0809 "Recommendations on Scale-Up and Postapproval Changes Guidances for Industry"
Thanks, Scott Kuzner, Ph.D., Senior
Director, Sciences and Regulatory Affairs, AAM