*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:
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:
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:
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:
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.