Apr 24, 2023· Comment from Association for Accessible Medicines (AAM)· FDA-2023-D-0044-0004
FDA, Please find attached comments from The Association for Accessible Medicines (AAM) regarding Docket No. FDA–2023–D–0044; Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA Guidance for Industry. Thanks, Scott Kuzner, Ph.D., Senior Director, Sciences and Regulatory Affairs, AAM