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Revised Guidance Clarifies FDA’s Expectations for Formal Meetings with Sponsors

April 1, 2015 | Hazar Awad Granko, RPh, PhD, Director, Regulatory Affairs | Regulatory Affairs

The FDA has outlined certain new procedures and associated timelines for sponsors seeking formal meetings to obtain feedback and guidance from the Agency during product development and review. If you’re planning on requesting an upcoming meeting with FDA, read on to learn more about some important changes that may impact you.

Background
In accordance with the PDUFA Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017, the FDA was tasked with updating the guidance on formal meetings between FDA and sponsors incorporating a series of agreed Meeting Management Goals.

The revised draft guidance for industry “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products” published in March 2015 revises the previous version (May 2009) and provides clarifications on formal meetings between sponsors and FDA relating to the development and review of products regulated by CDER and CBER.

The guidance does not apply to non-PDUFA products (ie, generics, biosimilars, or devices).

Under What Circumstances Can a Sponsor Meet with FDA?
As before, formal PDUFA meetings with FDA are classified into 3 meeting types:
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  • Type A Meeting: a meeting that is necessary for an otherwise stalled development program to proceed or to address an important safety issue (eg, dispute resolution meetings, meetings to discuss clinical holds, special protocol assessment meetings)
  • Type B Meeting: a routine meeting that occurs at a pre-defined milestone time point in the development program (eg, Pre-IND Meetings, certain End of Phase I Meetings, End of Phase II Meetings, Pre-NDA Meetings)
  • Type C Meeting: any meeting other than a Type A or Type B meeting regarding the development or review of a product

Image courtesy of Stuart Miles at FreeDigitalPhotos.net

There are no changes to the timelines during which each of these meeting types should be scheduled; Type A, B, and C Meetings should be scheduled to occur within 30, 60, and 75 days, respectively, of FDA receipt of a meeting request. If the sponsor requests a meeting date that is beyond these allotted timeframes, the meeting should be scheduled to occur within 14 calendar days of the requested date.

What Type of Meeting is this Anyway?
In the revised guidance, FDA has designated several additional meeting topics as either Type A or Type B meetings:

  • Post-action meetings requested within 3 months after an FDA regulatory action other than approval (ie, issuance of a complete response letter) are designated as Type A meetings while those requested 3 or more months after an FDA regulatory action other than approval are designated as Type B meetings
  • Meetings regarding REMS or postmarketing requirements that occur outside the context of the review of a marketing application are designated as Type B meetings
  • Meetings to discuss the overall development program for products granted breakthrough therapy designation status are designated as Type B meetings
  • Pre-emergency use authorization meetings are designated as Type B Meetings

Meeting Package Must Accompany Meeting Request for Certain Types of Meetings
Sponsors requesting a Type A Meeting with the FDA, typically the most urgent type of meeting, must now submit the Meeting Package concurrently with the meeting request. This is a change from previous requirements which allowed the Meeting Package to be submitted at least 2 weeks before the scheduled meeting date.

The FDA makes it very clear that they will deny requests for Type A Meetings that do not include the Meeting Package in the original request.

Image Courtesy of Stuart Miles at FreeDigitalPhotos.net

Meeting Packages for Type B and Type C Meetings are still required to be submitted at least 1 month before the scheduled meeting date.

soonFDA May Not Want to Meet… But they Promise to Write!
Stay tuned for more on the new “Meeting Granted Written Responses Only” format introduced in the updated guidance.

Need Help with Requesting a Meeting with FDA?
IMPACT’s team of highly experienced regulatory experts can help you navigate the FDA meeting process and assist with preparing thorough and compliant Meeting Requests and Packages. Contact us or give us a call at (919) 899‑9248 today to see how we can help!

Category: | Regulatory Affairs
Keywords: FDA, FDA Meeting, Guidance, PDUFA, CDER, CBER, Type A Meeting, Type B Meeting, Type C Meeting, Meeting Request, Meeting Package, Briefing Document

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