The Pre-Submission Program and Meetings with FDA Staff

The following four learning objectives will be addressed during this presentation. The first learning objective is to understand what a Q-Submission is, how to submit a feedback request to the FDA and important reminders when making such a request. Next, you will gain a better understanding of the various types of requests for FDA feedback that are tracked as Q-Submissions. Third, an overview of the recommended information which should be submitted in these requests for feedback. And lastly, a better understanding of when certain feedback requests are appropriate and when they are not.