Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products; Availability

The Parenteral Drug Association (PDA) is submitting the attached responses on behalf of a group of our members regarding FDA's discussion paper on Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products. The paper provided the industry with FDA perspectives on this issue and PDA's members have collaborated to collectively reply to the questions posed by the agency. In the attached comments, the team offers insight and suggestions that may assist the agency in formalizing and finalizing guidance related to Artificial Intelligence and Machine Learning. See attached file(s)