30 May FDA plans to release AI drug development guidance this year

By Joanne S. Eglovitch, Regulatory Focus

The US Food and Drug Administration (FDA) plans to release a draft guidance this year on the use of artificial intelligence/machine learning (AI/ML) to support drug development. The guidance will be informed by the agency’s experience in reviewing submissions containing AI/ML elements, as well as feedback it received on two discussion papers on the topic released last year, said Tala Fakhouri, associate director for policy analysis in the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER).

Fakhouri made these comments at the agency’s Regulatory Education for Industry (REdI) conference on Wednesday. FDA’s progress in developing a framework for AI was one of the topics of discussion, as well as the growing use of AI in regulatory submissions. Read more…