How to Deal with Unexpected Questions and Issues During Your Submission Process
Learn what next steps to take when unexpected questions and issues arise during your submissions process during this webinar on Managing Challenging Submissions.
In this one-hour webinar, you will learn how to:
- Minimize the risk of receiving a RTA Notification, Deficiency List, and / or AI Letter
- Respond to FDA communications regarding your submission
- Facilitate discussions with the Lead Reviewer
- Leverage recent FDA guidance documents and recognize FDA trends or themes that may impact your submission or review process
- Solicit and engage cross-functional support with engineering, quality, and new product development teams