Conducting Effective FDA Pre-Submission Meetings: Getting to Market Faster
Thu. February 7| 8:30 AM - 10:00 AM | 210D
Show: MD&M West 2019
Track: MD&M West: Regulatory & Quality Update
Badge Type: Paid
- When should the pre-sub process be used and how does it work?
- What information should be provided in advance and what should be provided at the meeting?
- What happens after the meeting, and are the results binding?
- Case examples demonstrating effective use of best practices to avoid timely and costly mistakes