Since 1995, the U.S. Food and Drug Administration (FDA) has received submissions for more than 300 drugs and biological products with artificial intelligence (AI) components and more than 700 AI-enabled devices, Commissioner Robert M. Califf, MD, said in a March 2024 blog post.  

Califf said that drug and device manufacturers are using AI for:

  • Drug discovery and repurposing
  • Biomarker assessment
  • Clinical trial design and endpoint assessment
  • Dose optimization
  • Postmarket safety surveillance

FDA is also exploring how it can use AI technologies to facilitate operations and regulatory processes, which Califf said could streamline workflows and enable high quality, novel medical products to more quickly reach the patients who need them.

At its most basic, AI can strengthen our operational systems and bring increased productivity, opportunity, and efficiency to our work, helping us process and analyze complex data faster, including data from medical imaging or digital health technologies, for example,” Califf said. “We can free up staff by automating repetitive administrative functions and enable them to focus on more complex meaningful activities to weigh the evidence and arrive at better decisions. Our workforce should also have more time to explain those decisions to the public and learned intermediaries in the biomedical and clinical world.”

FDA’s white paper, Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP Are Working Together, has more details about the agency’s approach to AI. You can also learn more about AI in oncology nursing on the Oncology Nursing Podcast Episode 281: Nursing’s Role in AI in Health Care and Episode 284: How AI Is Influencing Cancer Care and Oncology Nursing.