FDA Proposes Draft Guidance on Assessing the Credibility of AI Models Used in Drug and Biological Product Submissions
By EsqSocial Corporation 17/01/25
The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality. The agency noted an “exponential increase” in the use of AI in drug development and regulatory submissions in the last several years....
By: Orrick, Herrington & Sutcliffe LLP