Bringing Clarity to Regulatory Interactions: Proactive Strategies & FDA Updates to Align Analytical Expectations
Time: 9:30 am
day: Conference Day 1 Morning
Details:
- Gain insight into recent FDA leadership and organizational changes, as well as how they influence evolving policy development and its practical enforcement in analytical development
- Explore tactics for presenting data and negotiating assay specifications that reflect real-world manufacturing capabilities and clinical realities
- Learn how early, well-structured engagement with regulators can help align on assay expectations, minimize rework, and support smoother progression through pivotal milestones
