What is the Type D meeting?
The FDA introduced the Type D Meeting on October 1, 2022, as part of the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter. This new meeting is designed to make it easier and faster for sponsors to get their questions answered.
Prescription Drug User Fee Act (PDUFA) VII
The Prescription Drug User Fee Act (PDUFA VII) is a law that was signed and took effect on September 30, 2022. It is the sixth reauthorization of PDUFA that provides the FDA with necessary resources and includes provisions to increase the efficiency of the drug development process. PDUFA VII will be in effect from fiscal year 2023 through fiscal year 2027. Check out our previous blog post to learn more about changes that came in PDUFA VII.
Type D Meeting – PDUFA VII New Formal Meeting
Under the PDUFA VII commitment letter, the FDA will respond to Type D meeting requests within 14 calendar days and schedule a meeting or provide a written response within 50 calendar days from receipt of the meeting request. Type D Meetings are limited to two focused topics and should not require input from more than three disciplines or divisions. This narrow focus makes Type D meeting timelines shorter than Type C meetings. Some examples of topics to be covered include:
- A follow-up question that raised a new issue after a formal meeting
- A specific, narrow issue with a few associated questions
- A general question about an innovative development that does not require extensive or detailed guidance
How to Request a Type D Meeting
To request a Type D Meeting, the sponsor must submit a meeting request to the FDA. The meeting request should include:
☐ The meeting topic(s) – the topics should be limited to no more than 2 focused topics
☐ The proposed meeting format (teleconference, virtual, written, or in-person)
☐ The proposed date(s) and time(s) available for the meeting
☐ The proposed agenda with estimated times
☐ The list of objectives/outcomes
☐ The date that the meeting background package will be sent to the center
☐ The list of requested representative(s) from the Center with explanation for the request
☐ The names and contact information for the sponsor or sponsor representative(s) who will attend the meeting
The FDA will review the meeting request and either approve or deny it. If approved, the FDA will send a meeting confirmation letter to the sponsor with the meeting details, including the date, time, format, and location. If the meeting scope exceeds that of a Type D meeting, the FDA will notify the sponsor and offer to convert the meeting to a Type B or Type C meeting. The sponsor can then choose to withdraw their request or accept the meeting-type conversion.
Meeting Management Goals
|Meeting Type||Meeting Request Response Time||Meeting Scheduling|
|D||14 days||50 calendar days from FDA request receipt|
|Meeting Background Package Due Date||Meeting Minutes|
|At the time of the meeting request||Agency will provide within 30 calendar days after the meeting|
The Type D Meeting is a valuable new tool for sponsors to receive early feedback from the FDA on specific issues. Premier Consulting can help you schedule any FDA meeting, from Type A to Type D, and provide you with the guidance and support you need to get the most out of your meeting. Contact us today.
Author: Jorge Sierra, Regulatory Operations Associate III