Jan 14, 2025· Comment from Association for Accessible Medicines (AAM)· FDA-2024-D-4624-0006
FDA, Please find attached comments from the Association for Accessible Medicines (AAM) regarding Docket No. FDA-2024-D-4624 "Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics; Draft Guidance for Industry" Thanks, Scott Kuzner, Ph.D., Senior Director, Sciences and Regulatory Affairs, AAM