Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry and Other Interested Parties; Draft Guidance

Nexus Concordat Inc. supports the draft guidance but proposes expanding it to recognize a specific category of "compiler-verified synthetic twins" based on biochemistry-closed opcode sets. They argue that these substrate-grounded AI systems offer deterministic, bit-for-bit reproducible results and should be subject to tailored credibility-assessment expectations based on their architectural properties rather than just behavioral evidence.

Dr. Lamia Anwar, representing the Egyptian Drug Authority, supports the draft guidance as an important step toward responsible AI use in drug development. The commenter suggests specific improvements to the guidance, including clearer scope definitions, objective risk scoring, explicit bias mitigation strategies, and better alignment with international harmonization standards.

GE HealthCare supports the FDA's draft guidance on using AI for regulatory decision-making and appreciates the agency's recommendations. The company suggests that the FDA also consider incorporating the Failure Mode and Effects Analysis (FMEA) framework as a systematic approach for identifying, evaluating, and mitigating risks associated with AI models.

The commenter provides constructive feedback and suggestions to improve the draft guidance on AI in regulatory decision-making. They recommend expanding the scope to include combination products, adding a glossary of terms, and providing more specific examples of model risk categories and GXP impacts.

Flagship Pioneering, a biotechnology company, supports the FDA's draft guidance but urges the Agency to balance patient safety with the need to foster innovation by avoiding overregulation. They recommend narrowing the scope of oversight to AI applications that directly impact patient safety, providing clearer risk-based requirements, and establishing a centralized AI council to facilitate early engagement with developers.

The LUNGevity Foundation, a lung cancer nonprofit, supports the draft guidance on using AI in regulatory decision-making for drug and biological products. They recommend providing more specific guidance on early consultation with the FDA, methodological transparency (including an optional template), defining the context of use across different programs, and clarifying risk assessment and performance evaluation metrics.

The REMS Industry Consortium (RIC) supports the FDA's draft guidance on using artificial intelligence for regulatory decision-making. They specifically applaud the risk-based credibility assessment framework and the FDA's commitment to early engagement with sponsors and stakeholders.

IQVIA, a global provider of advanced analytics and clinical research services, supports the FDA's draft guidance on using AI for regulatory decision-making. They recommend enhancing the guidance by emphasizing real-world testing, incorporating life-cycle monitoring into the core framework, and including specific considerations for generative AI models.

Cruelty Free International supports the proposed guidance but urges the FDA to explicitly emphasize and include examples of AI applications that can replace, rather than just reduce, animal testing. They argue that prioritizing human-relevant data and modern AI models will improve drug development outcomes, reduce costs, and align with ethical standards.