FDA Issues Draft Guidance on Using AI in Regulatory Decisions for Drugs
January 07, 2025
January 07, 2025
WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) has unveiled a draft guidance for the use of artificial intelligence (AI) in regulatory decision-making concerning drug and biological products. This document provides recommendations to industry stakeholders on how AI-generated data can support regulatory determinations about safety, effectiveness, and quality.
Developed in collaboration with multiple FDA centers, the draft emphasizes a risk-based credibility ass . . .
Developed in collaboration with multiple FDA centers, the draft emphasizes a risk-based credibility ass . . .