Mar 4, 2025· Comment from Association for Accessible Medicines (AAM)· FDA-2024-D-2033-0030
FDA, Please find attached comments from the Association for Accessible Medicines (AAM) regarding Docket No. FDA-2023-D-5016 "Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry" Thanks, Scott Kuzner, Ph.D., Senior Director, Sciences and Regulatory Affairs, AAM