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Understanding the Revised Draft Guidance for Formal Meetings with the FDA

Understanding FDA's Revised Draft Guidance: PDUFA Formal Meetings

Are you looking for rapid feedback from the FDA on a specific topic related to your product development program? Wondering which meeting request you should submit? Let’s delve into the latest updates.

On September 22, 2023, the FDA released the eagerly anticipated revised draft guidance titled “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.” This guidance outlines six distinct formal meeting types under the Prescription Drug User Fee Act (PDUFA) for sponsors seeking interaction with the FDA. They include:

  • Type A
  • Type B
  • Type B (end of phase or EOP)
  • Type C
  • Type D
  • Initial Engagement for Regulatory Advice on CDER and CBER Products (INTERACT)

Of these, Type D and INTERACT are the latest additions to the draft guidance.

So, what exactly are these new meeting types?

Type D meetings are designed to address “a narrow set of issues” – essentially crucial decision points. These meetings facilitate timely feedback, helping to advance the drug program. Here, sponsors can raise questions centered on no more than two specific topics. Importantly, the topics shouldn’t necessitate input from over three FDA disciplines or divisions. After submitting a Type D meeting request, sponsors can expect a response from the FDA within 14 days, with the meeting scheduled within 50 days.

While INTERACT meetings aren’t entirely new (they were introduced to PDUFA VII last September), they cater to unique challenges and innovative questions for CDER and CBER products in their initial development stages, like pre-pre-IND. These meetings enable sponsors to gain FDA insights early in the drug development phase, even before their IND filing. Topics for discussion could include:

  • Advanced manufacturing technologies or processes
  • Design strategies for IND-enabling toxicology studies
  • Innovative devices associated with drugs or biologics
  • The use of “New Approach Methodologies”

Similar to Type D, sponsors need to provide background packages or briefing documents when requesting an INTERACT meeting. The FDA typically responds within 21 days of such a request, arranging the meeting within the subsequent 75 days.

Circling back to our initial query, if you’re dealing with a singularly focused topic requiring input from a maximum of three FDA disciplines or divisions, a Type D meeting request is your answer. However, remember that navigating FDA meetings can be intricate. While you may perceive a meeting one way, the FDA might view it differently, especially concerning the number of disciplines or divisions involved. Fortunately, our seasoned team at MMS is here to assist with all your regulatory challenges.

Eager to learn more about navigating FDA meetings? Please click here to connect with our regulatory experts today.

Authored by: Nancy Hsu, Regulatory Affairs Associate, Regulatory Affairs.