Comment from Global Key Solutions Corp.
AnonymousSupportBusiness
Summary: Global Key Solutions Corp. provides detailed feedback on the draft guidance, suggesting specific terminology changes and clarifications to ensure AI's role is accurately represented as "assisting" rather than "supporting" decisions. They also advocate for clearer definitions regarding human oversight, life cycle maintenance, and the role of the Quality Unit in overseeing AI systems.
Refer to the attachment 1 for Global Key Solutions Corp. comments on the entire document, Docket Number FDA-2024-D-4689, “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request”.