FDA Revises Formal Meetings Guidance for PDUFA Products
April 6, 2015By Alexander J. Varond –
After six years of operating under its May 2009 “Guidance for Industry: Formal Meetings Between the FDA and Sponsors of Applicants,” FDA refreshed its guidance. On March 11, FDA announced its draft guidance entitled “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act (PDUFA) Products.”
Despite the amount of time that passed since the last version was issued, the draft guidance makes relatively few changes. This is fairly impressive, given the importance of FDA meetings; but this also speaks to the relative maturity of the PDUFA program—now in its fifth incarnation. We posted an in-depth discussion about the 2009 guidance here.
In the chart below, we provide a brief overview of each meeting type and highlight the changes made by the draft guidance document.
Table 1: Summary of Meeting Types and an Overview of Changes
Meeting Type | TYPE A MEETING | TYPE B MEETING | TYPE C MEETING |
Meeting Timing (days after FDA’s receipt of request) | 30 days | 60 days | 75 days |
New meeting designations (added by draft guidance) | Post-action meeting requested within 3 months after an FDA regulatory action other than approval | Breakthrough therapy development meetings (meetings to discuss overall development programs for breakthrough therapy-designated products) Post-action meetings requested ³3 months after an FDA regulatory action other than approval Risk evaluation and mitigation strategies (REMS) or postmarketing requirements meetings that occur outside the context of the review of a marketing application | N/A |
Meeting designations (existing) | Meetings that are necessary for an otherwise stalled development program to proceed or to address an important safety issue, including: Dispute resolution meetings Meetings to discuss clinical holds Special protocol assessment meetings | Pre-IND meetings Pre-emergency use authorization meetings Certain end-of-phase 1 meetings for subpart E or subpart H or similar products End-of-phase 2/pre-phase 3 meetings Pre-NDA/pre-BLA meetings | Any meeting other than a Type A or Type B meeting regarding the development and review of a product |
Additional draft guidance changes | Meeting packages must be submitted with Type A meeting requests (in the past, a Type A meeting package could be submitted 2 weeks prior to the meeting date) | Sponsors can now request written responses to pre-IND questions rather than face-to-face meetings, videoconferences, or teleconferences | Sponsors can now request written responses to Type C meetings rather than face-to-face meetings, videoconferences, or teleconferences |
Meeting package due date | Must be submitted at the same time as the meeting request | 1 month prior to meeting | 1 month prior to meeting |
The draft guidance also clarifies the appropriate timeframe for scheduling meetings. In the 2009 guidance FDA stated “If a sponsor or applicant requests a meeting date that is beyond [30/60/75] days from the date of the request receipt, we will work with the sponsor or applicant to determine the earliest agreeable date.” (Emphasis added). The last clause has been made more specific, such that the scheduling requirement is now “If a request for a meeting date that is beyond [30/60/75] days from the date of the request receipt, the meeting date should be within 14 calendar days of the requested date.” (Emphasis added).