Comment from Ildiko Ziegler
AnonymousSupportIndividual
Summary: Dr. Lidiko Ziegler, an independent pharmaceutical quality expert, supports the draft guidance and suggests specific additions to improve its utility. The commenter recommends including requirements for data quality, a structured AI validation framework (pre-, during, and post-validation), clear triggers for model retraining, and the establishment of a database for post-market surveillance.
Comments on docket number: FDA-2024-D-4689
Draft Guidance for Industry and Other Interested Parties
Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products (January 2025)
Dear Commissioner Dr. Califf, Dear Dockets Management Staff,
As an experienced expert (20+ years career) in building and developing Pharmaceutical Quality Management Systems for pharmaceutical development and manufacturing both in the start-ups and in large organizations, always in collaboration with regulatory practitioners. I have always been keen on modern information technology and especially the ways how these modern technologies are able to support innovation and pharmaceutical development.
I appreciate the opportunity to comment on the newly released draft guidance document “Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products”, which has been open to public comments since 04/07/2025. I am providing my comments as an independent consulting expert. I would be happy to collaborate with the FDA and to serve as a useful participant in finalizing the AI guidance.
My comments are attached.