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Interactions with the FDA During the IND/NDA Phases


Establishing a good working relationship and open communication with the FDA is essential to the development of any regulated product. To ensure efficient communication, FDA has established very specific and formal ways for the industry to interact with FDA personnel. It is critical that every regulatory affairs professional, as well as other project team members, understand these methods of communication with FDA and how to use them appropriately and effectively.
In this beginner online course, you will learn the various methods for communicating with the FDA, including telephone calls, emails, faxes, and meetings.  Special attention is given to the types of formal FDA meetings available to industry, as well as specific details on how and when to request them.  Finally, you will receive specific recommendations, based on the experience of leading regulatory affairs professionals, on how to conduct successful and productive meetings with FDA.

This On Demand Training will take approximately 2 hours to complete.

Featured topics

  • FDA’s Guidance on Meetings
  • Time Course of Events in Requesting a Meeting
  • Objectives and Conduct of Specific Meetings With FDA
  • Principles for Communicating with FDA
  • Meeting Etiquette
  • How to Resolve Issues or Disputes with FDA
  • Summary on Interacting with FDA
  • Advisory Committee Meetings

Who should attend?

  • Regulatory affairs professionals new to the IND/NDA processes
  • Clinical development professionals
  • Biostatisticians
  • Basic researchers
  • Quality and manufacturing professionals
  • Medical writers
  • Business and marketing professionals
  • Clinical research academicians

Learning objectives

At the conclusion of this activity, participants should be able to:

  • Apply formal meeting principles and practices when interacting with the FDA during the IND/NDA phases
  • List time course of events for sponsors in requesting a Type A, B, or C meeting with FDA

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