As FDA considers the application of its risk-based regulatory framework to the use of AI technologies in drug manufacturing, the Agency has identified in this discussion paper areas for which public feedback would be valuable. CDER scientific and policy experts identified these areas from a comprehensive analysis of existing regulatory requirements applicable to the approval of drugs manufactured using AI technologies.1 The areas of consideration in this discussion paper are those for which FDA would like public feedback.

There are additional areas of consideration not covered within this document; for example, difficulties that could result from potential ambiguity on how to apply existing Current Good Manufacturing Practice (CGMP) regulations to AI or lack of Agency guidance or experience.

The areas of consideration presented in this discussion paper focus on the manufacture of drug products that would be marketed under a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA).
Public feedback will help inform CDER’s evaluation of our existing regulatory framework.

While the initial analysis focused on products regulated by CDER, FDA’s Center for Biologics Evaluation and Research (CBER) has also encountered a rapid emergence of advanced manufacturing technologies associated with AI. As such, both CDER and CBER stakeholders are invited to provide feedback on the discussion questions


Artificial Intelligence in Drug Manufacturing