FDA Breifing on its activities related to "Artificial Intelligence and Machine Learning (AI/ML) for Drug Development"

The FDA posted a brief update on its activities related to AI and ML on 10May23.

In it it notes that there were 100 submission in 2021 that included some form of AI or ML, and covered a broad range " of drug development — from drug discovery and clinical research to postmarket safety surveillance and advanced pharmaceutical manufacturing."

The three divisions involved in ensuring the safety of drugs and biological products, CDER, CBER and CDRH, were all involved with the issuance of an initial discussion paper (references below).

Related Publications

• FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing
• AI/ML for Drug Development Discussion Paper (PDF - 1 MB)
• CDER Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative, including discussion papers:
  • Artificial Intelligence in Drug Manufacturing (PDF - 2 MB)
  • Distributed Manufacturing and Point-of-Care Manufacturing of Drugs (PDF - 1 MB)
• For specific AI/ML publications related to devices, please visit CDRH’s Digital Health Center of Excellence webpage