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Evaluation ViewAttendees 42

Sponsor Presentation

Sponsored Presentation: Proactivity and best practices in the evolving FDA landscape

Wednesday, October 8, 2025
10:45 AM - 11:10 AM EST
Location/Room: Exhibit Hall: Ignite! Theater Booth 925
In this session, the speakers will share recent insights from their consulting work across many FDA review divisions, with a specific focus on lessons learned and communication best practices in this ever-evolving FDA landscape. From IND and marketing application reviews to informal and formal feedback pathways, the speakers will present their experience accrued over many FDA interactions and application reviews this year, along with a few case studies. The lessons shared during this session will promote more efficient regulatory communications and review processes for companies with US development programs.

Learning Objectives:

  • Understand how AI technologies can support key components of the clinical evaluation process under EU MDR.
  • Identify which tasks in CER development are best suited for AI assistance, including literature review, data extraction and data synthesis.
  • Evaluate compliance considerations and potential pitfalls when incorporating AI tools into regulated documentation.
  • Apply best practices for integrating AI outputs into human-led quality systems and regulatory submissions.