M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines; International Council for Harmonisation; Draft Guidance for Industry; Availability

FDA, Please find attached comments from the Association for Accessible Medicines (AAM) regarding Docket No. FDA–2024-D-2560 - "M14 General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines; Draft Guidance for Industry" Thanks, Scott Kuzner, Ph.D., Senior Director, Sciences and Regulatory Affairs, Association for Accessible Medicines (AAM)