🇺🇸 U.S. Food and Drug Administration (FDA) Framework for AI Models in Regulatory Submissions

The FDA published a draft framework for assessing Artificial Intelligence and Machine Learning models used in drug and biological-product submissions.

What This Means for You:
If your company uses digital tools, data analytics, or AI in regulatory workflows, expect heightened scrutiny on algorithm transparency, validation, and auditability. Plan early for data-integrity evidence within eCTD or eTMF documentation.