Advancing pharmaceutical processes with AI: The FDA's perspective

As artificial intelligence (AI) and machine learning (ML) continue to revolutionize various industries, the pharmaceutical sector is no exception. Indeed, there has been a substantial surge in drug and biologic submissions incorporating AI/ML components, exceeding 100 submissions in 2021 alone.1

Recognizing the profound impact of AI on all aspects of the pharmaceutical industry, the US Food and Drug Administration (FDA) has embarked on a journey to navigate the opportunities and challenges presented by these technologies.

AI for drug development