Feb 3, 2023· Comment from Association for Accessible Medicines (AAM)· FDA-2001-D-0197-0009
FDA, Please find attached comments from The Association for Accessible Medicines (AAM) regarding Docket No. FDA–2001–D–0197, Statistical Approaches To Establishing Bioequivalence. Thanks, Scott Kuzner, Ph.D. Senior Director, Sciences and Regulatory Affairs Association for Accessible Medicines (AAM)