Feb 28, 2025· Comment from Association for Accessible Medicines (AAM)· FDA-2023-D-5016-0039
FDA, Please find attached comments from the Association for Accessible Medicines (AAM) regarding Docket No. FDA-2023-D-5016 "Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry" Thanks, Scott Kuzner, Ph.D., Senior Director, Sciences and Regulatory Affairs, AAM