Case Study: Turning Your FDA Relationship into a Core Competency to Streamline Review Processes
- Practical walkthrough of a submission journey including pre-sub meetings, review questions, and lessons learned, followed by discussion
- What regulators expect in modern software and AI submissions
- Structuring documentation for clarity, traceability, and review efficiency
- Managing pre-submission interactions and mid-review information requests
- Lessons learned from successful and delayed software submissions