Aug 25, 2025· Comment from Association for Accessible Medicines (AAM)· FDA-2025-D-1106-0014
FDA, Please find attached comments from the Association for Accessible Medicines (AAM) regarding Docket No. FDA-2025-D-1106 "Q1 Stability Testing of Drug Substances and Drug Products; International Council for Harmonisation; Draft Guidance for Industry." Thanks, Scott Kuzner, Ph.D., Senior Director, Sciences and Regulatory Affairs, AAM