Comment from BioPhorum
AnonymousSupportAdvocacy
Summary: BioPhorum, representing the biomanufacturing industry, expresses strong support for the FDA's draft guidance on using AI for regulatory decision-making, praising its risk-based and non-prescriptive approach. The organization provides detailed technical recommendations to improve the guidance, including clearer definitions for AI/ML terms, more specific examples for model credibility assessments, and a focus on outcome validation over impractical methodological transparency.
BioPhorum represents the perspective of the biomanufacuting industry, which is not only at the elm of innovation for the delivery of new modalities to cure patients but also at the elm of innovative approaches,including the use if AI. BioPhorum represents over 150 biomanufacturers, their drug delivery and other suppliers