Most of us are trying to simplify our schedules and remove meetings from our calendars. However, there is one scenario where the potential for more meetings is actually a good thing. That is when you are preparing to submit a regulatory application to a health authority, such as an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA). Getting the FDA’s input into your application prior to submission is a critical step in the process. Because the meetings are typically scheduled for about an hour to an hour and a half, making good use of your time with the health authority is key.
The FDA is now encouraging sponsors to hold more than one pre-IND meeting to get the answers to critical questions standing between them and an open IND. This change in practice denotes a renewed commitment on the part of the FDA to communicate more effectively. It also gives Sponsors a great opportunity to ask questions as they arise and to hone in on more successful regulatory development pathways.
Pre-IND meetings require significant planning. Development of a background package should follow recommended practices documented in the Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products. The guidance outlines a series of efficient and consistent procedures that help both the agency and the Sponsor participate in a well-managed and efficient meeting. For sponsors who are new to this process, the agency recommends that the sponsor partner with a contract research organization (CRO) or consulting entity (such as Facet) who can help to navigate the complex requirements and ensure a successful meeting and subsequent submission. These are not just “shoot the breeze” conversations with FDA and the outcome of the meeting is commensurate with the planning done prior to the meeting.
The agency also offers other online resources to address scientific and regulatory issues that are not covered in established guidance, policy, and procedures. Sponsors are encouraged to take advantage of these resources as part of their preparation for an agency meeting.
It should be noted that there a no government fees to meet with the agency. This stands in contrast with scientific advice meetings in European Union where government fees are associated with agency meetings.
If an IND is in your future, your pre-IND meeting with the FDA will be a major milestone for your company and product. Make the most of this opportunity and enlist help to ensure the best outcome possible. This brief Points to Consider Checklist is designed for early-stage teams who are starting to think about their IND and pre-IND meeting.
You can also check out our webinar recording: Your First IND: Ready, Set Go!
Facet Life Sciences attends FDA meetings with Sponsors on average once every 3 weeks! We can help you decide if a pre-IND meeting is right for you. We can also help you to request your meeting and prepare your background package. Our scientific regulatory experts can attend the meeting with you and help you to develop your IND application. We’ll partner with you to ensure your success in getting “to and through the FDA”!