Comment from Bhasker Sambar

Division of Dockets Management (HFA 305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 Re: 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for the Use of Artificial Intelligence to Support Regulatory Decision Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Comment Request.” I am submitting the enclosed comments for the Agency’s consideration regarding the Draft Guidance titled “Considerations for the Use of Artificial Intelligence To Support Regulatory Decision Making for Drug and Biological Products.” I appreciate the opportunity to provide input on this important topic. My comments reflect 15 years of practical experience in pharmaceutical development and CMC operations, along with current knowledge involving the application of AI and digital tools in regulated environments. I respectfully request that the Agency consider these perspectives as it continues to refine the framework for the use of AI in regulatory decision making. Recommendations to FDA: 1. Title and Scope (Section II) The title includes “drug and biological products,” but Section II doesn’t clarify how combination products fit. Please include it for clarification. 2. Section IV Section IV provides detailed examples for Steps 1–3 with Drug A and Drug B but does not extend these examples through Steps 4–7. As a result, the guidance does not fully demonstrate the process. Please extend the examples to Steps 4–7. 3. All Expectations for vendor supplied or third party AI models, including documentation and verification requirements, are not included. I believe most pharmaceutical companies initially rely on third party AI models. Please clarify and add high level differences (if any). 4. Page 8 Section III briefly mentions: “Other types of risk, such as cybersecurity risk, are out of scope…” But cybersecurity and data integrity are critical for AI models. Recommend FDA include at least a high level statement on cybersecurity expectations or reference relevant guidance. Please feel free to contact me if any clarification is needed. Sincerely, Bhasker Sambar Email: bashu1986@gmail.com Sr. Manager, External R&D https://www.linkedin.com/in/bhasker-sambar-b5052933 Please note that, I submitted the same comments just few minutes ago. There is a typo for what is your comment about. As per the FDA' Q&A, I resubmitted with the same technical content and selected the right option for the comment category 'Drug Industry - C0022'.