*Published on November 16, 2022
On October 1, 2022, as part of the Prescription Drug User Fee Act reauthorization (PDUFA VII), the FDA introduced a new Type D meeting that makes it easier and faster for sponsors to have their questions answered. This blog will break down the new meeting guidelines and goals, and provide additional resources, including a revised FDA meeting timeline.
Details of the Type D meeting
The Type D meeting creates an opportunity for sponsors to have questions answered by the FDA on an accelerated timeline due to a more limited content range. The Agency defines the Type D meeting as, “a meeting focused on a narrow set of issues (should be limited to no more than 2 focused topics) and should not require input from more than 3 disciplines or Divisions.”
Unlike the Type C meeting, which may cover a broader spectrum of topics, the Type D meeting limits the discussion scope to 1 or 2 defined topics; therefore, the overall meeting timeline is more immediate than the Type C meeting.
Examples of when a Type D meeting would be appropriate include:
- A question following up after a formal FDA meeting that introduces a new issue, beyond just a clarifying question after a prior meeting.
- A sponsor asking for FDA input around a narrow topic with a few associated questions.
- A general question regarding an innovative development in which extensive, detailed advice is not needed.
When to move to a Type B or Type C meeting
Though the more compressed timeline of the Type D meetings is advantageous for sponsors, it’s important to recognize the boundaries of this meeting. If the FDA believes the meeting request falls outside the limited scope of the Type D meeting, they will:
- Convert the meeting to the appropriate meeting type.
- Inform the sponsor of the change.
- Ask if the sponsor would like to proceed with the new meeting type (B or C).
The sponsor can then withdraw their request or accept the new meeting type without refiling their initial request.
To keep the Type D meetings expeditious, the following reasons are grounds for moving the meeting to a Type B or Type C:
- All information discussed should not come from over 3 Divisions or disciplines.
- The sponsor is seeking input around a broad topic with several issues or a complicated single issue that includes multiple questions.
Goals of the Type D meeting
The FDA has outlined specific performance goals for the Type D meeting that start in fiscal year (FY) 2023, as outlined in the PDUFA VII reauthorization goals for FY 2023 - 2027. The goals increase each FY, while the parameters remain the same.
Starting in FY 2023, the FDA will hold 50% of Type D meetings, or deliver a response in writing, within 50 calendar days after receiving the meeting request. This increases as follows for Type D meetings:
- 60% by 2024
- 70% by 2025
- 80% by 2026
- 90% by 2027
Additionally, by July 30, 2024, the FDA will hold a public forum to discuss best practices related to meeting management. Topics to be reviewed include meeting request submission and efficient time management. Metrics, such as the number of Type D meetings (among others) requested and denied, will also be shared.
Comprehensive meeting timeline
The following timeline includes the new Type D meeting. It was created by Premier Consulting and is based on the PDUFA VII Commitment Letter.
|
Meeting Type |
Response Time (Calendar Days) |
Receipt of Background Package |
Meeting Scheduling or Written Response Time |
|
A |
14 |
At the time of the meeting request |
30 calendar days from the receipt of the meeting request |
|
B |
21 |
30 calendar days before the date of the meeting or expected written response |
60 calendar days from the receipt of the meeting request |
|
B(EOP) |
14 |
50 calendar days before the date of the meeting or expected written response* |
70 calendar days from the receipt of the meeting request |
|
C |
21 |
47 calendar days before the date of the meeting or expected written response* |
75 calendar days from the receipt of the meeting request |
|
D |
14 |
At the time of the meeting request |
50 calendar days from the receipt of the meeting request |
*If the scheduled date of a Type B(EOP) or C meeting is earlier than the timeframes specified above, the meeting background package will be due no sooner than 6 calendar days following the response time for Type B(EOP) meetings and 7 calendar days for Type C meetings.
EOP = end of phase.
Key takeaway
The new Type D option gives sponsors a faster way to schedule an FDA meeting to discuss a focused scope of issues, usually with no more than 2 narrow topics. For subjects that meet the limited Type D criteria, this new meeting is a galvanizing game changer offering sponsors a quicker way to get their questions answered.
How Bracken can help
Bracken’s group of regulatory experts is ready to assist your development team to navigate not only the new Type D meeting parameters, but all health authority interaction—from initial filing through regulatory approval.
