The FDA’s “Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; Request for Information and Comments” was open to comments until 1 May 2023. It aims to address areas for consideration and policy development identified by the Center for Drug Evaluation and Research (CDER) scientific and policy experts associated with application of artificial intelligence (AI) to pharmaceutical manufacturing.

The focus is on advanced manufacturing. i.e. innovative pharmaceutical manufacturing technologies and approaches that may improve the reliability and robustness of the manufacturing process and the resilience of the supply chain. Artificial intelligence may play an important role in monitoring and controlling advanced manufacturing processes. The discussion paper addresses the main areas of consideration with respect to the FDA’s existing risk-based regulatory framework, as emerged from a comprehensive analysis of existing regulatory requirements applicable to the approval of drugs manufactured using AI technologies. The document focuses on drug products that would be marketed under a new drug application (NDA), abbreviated new drug application (ANDA), or biologic license application (BLA).