FDA Guidance for Industry: Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products and Other Interested Parties
Title:
FDA Guidance for Industry: Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products and Other Interested Parties
Origin/Publisher:
FDA
Content:
This guidance provides recommendations to sponsors and other interested parties on the use of artificial intelligence (AI) to produce information or data intended to support regulatory decisionmaking
regarding safety, effectiveness, or quality for drugs.5