Comment from Certara
AnonymousSupportBusiness
Summary: Certara, a pharmaceutical services company, supports the draft guidance but requests more specific details and clarity. They specifically ask for a clearer risk matrix, more complex examples, precise definitions for "training" versus "tuning," and recommendations for specific meeting types (like Type D meetings) to discuss AI development with the FDA.
Certara welcomes the opportunity to comment on the FDA guideline, our comments are provided in the attached document