Comment from Animal Health Institute
AnonymousSupportTrade association
Summary: The Animal Health Institute (AHI), a national trade association representing animal health product manufacturers, supports the proposed guidance on using AI in regulatory decision-making. They advocate for a risk-based approach and provide specific recommendations to enhance the guidance, including clarifying data requirements, expanding the credibility framework to include various model types (like LLMs and regression models), and incorporating a structured model development plan.
The ANIMAL HEALTH INSTITUTE (AHI) submits these comments to Docket ID: FDA-2024-D-4689: Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products. AHI is the national trade association representing manufacturers of animal health products – the pharmaceuticals, vaccines and feed additives used in modern food production, and the medicines that keep livestock and pets healthy. AHI member companies are pleased to provide the comment on this guidance. Please see the attached comments.