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New PDUFA V Meeting Timelines

PDUFA V ushered in new industry and FDA commitments.  Among these are changes in meeting timelines. A significant change from PDUFA IV is the timeline for Type A meetings. Under PDUFA IV the meeting package was due 30 days in advance of the meeting.  Now, under PDUFA V, this package is due at the time of the meeting request.  A summary of the timelines for the various meeting types is presented in the following table. Please note that the FDA review divisions are still implementing these changes, so there will be some flexibility in these requirements and timelines.

 

Meeting Description Meeting Scheduled or Granted by FDA Meeting or Written Response Date Meeting Package Due
Type A A meeting which is necessary for an otherwise stalled drug development program to proceed (a “critical path” meeting) or to address an important safety issue. [Interpret as: stalled as a result of an FDA decision, not a sponsor business decision/situation]Eg, a post-action meeting requested by the sponsor within three months after an FDA regulatory action other than an approval (ie, issuance of a complete response letter). Within 14 days of receipt of  meeting request Within 30 days of  receipt of request At time of meeting request letter
Type B
  • pre-IND
  • end of Phase 1 (for Subpart E or H)
  • end of Phase 2/pre-Phase 3
  • a pre-NDA/BLA meeting.

Each requestor should usually only request 1 each of these Type B meetings for each potential application.

Within 21 days of receiving meeting request. PIND request may receive notification of  written responses in place of meeting. Within 60 days of receipt of request At least 1 month in advance of meeting date
Type C Any other type of meeting. Within 21 days of receiving meeting request OR notification that written responses will be sent in place of meeting Within 75 days of receipt of request At least 1 month in advance of meeting date
Special Protocol Question Assessment Upon specific request by a sponsor the Agency will evaluate certain protocols and issues to assess whether the design is adequate to meet scientific and regulatory requirements. NA Agency response to questions within 45 days NA
Complete Response to Clinical Hold Complete response to clinical hold (an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation) requesting that the hold be removed. NA Agency response within 30 days of Sponsor’s complete response NA
Notes:
  •          These timelines are the goal for 90% of requests.
  •          Meeting requests must be written (letter or fax).
  •          FDA Meeting minutes will be available to Sponsor within 30 days of meeting date.
  •          Draft guidance on formal meetings to be published no later than end of FY 2013.
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