Comment from Association for Accessible Medicines (AAM)
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Summary: The Association for Accessible Medicines (AAM), representing generic and biosimilar pharmaceutical manufacturers, supports the draft guidance on protocol deviations. They provide specific suggestions to improve the guidance, such as including Contract Research Organizations (CROs) in the scope, clarifying reporting requirements for imaging files, and requesting specific timelines for reporting important deviations.
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Docket No. FDA-2023-D-5016 "Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry" Thanks, Scott Kuzner, Ph.D., Senior Director, Sciences and Regulatory Affairs, AAM