Webinar

Managing Regulatory Submissions


Unexpected Questions & Issues During the Regulatory Submission Process

Learn what next steps to take when unexpected questions and issues arise during the regulatory submission process. In this one-hour webinar, Managing Challenging Submissions, 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 regulatory submission
  • Facilitate discussions with the Lead Reviewer for the regulatory submission
  • Leverage recent FDA guidance documents and recognize FDA trends that may impact your regulatory submission
  • Solicit and engage cross-functional support with engineering, quality, and new product development teams

Please note that functional cookies must be enabled to access this content.

Register to Watch the Webinar