The FDA has issued a final version of its meeting-request guidance under the Prescription Drug User Fee Act, broadening the circumstances in which agencies may reply in writing. The draft version was released on September 22, 2023, and the agency solicited comments from the public. Compared with that draft, the final text introduces several adjustments, most notably a revision of the circumstances under which INTERACT meetings may be used. The earlier draft had supplanted the December 2017 guidance and created two additional meeting categories, D and INTERACT.
In the 2023 draft, INTERACT meetings were described as a venue for “novel products and development programs that present unique challenges in early development (i.e., before filing of an IND or before having a pre-IND meeting).” The finalized guidance now limits this category, specifying that INTERACT meetings are “not the appropriate meeting type” for sponsors who have already held a pre-IND meeting or submitted an IND. This change answers a comment from the Biotechnology Innovation Organization (BIO) that asked the agency to differentiate INTERACT sessions from pre-IND meetings. The provisions for Type D meetings stay the same, while the new version supplies three additional illustrative scenarios.
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The updated rule also permits the FDA to provide a written response only (WRO) in place of a live discussion for Type B (pre-IND), C, D and INTERACT meetings, irrespective of the format the sponsor requested. For all other meeting categories, a written response may replace a live session only if the requester specifically asks for it. In its feedback on the draft, BIO “encourage[d] the FDA to outline the criteria applied in determining the appropriateness of WRO,” noting that “Industry Sponsors have experienced an increasing shift towards use of WRO in lieu of teleconference or face-to-face meetings, even for meetings intended to address complex topics such as INTERACT meetings.”
The final guidance expands Type B meetings to cover pre-sNDA and pre-sBLA discussions. It also adds a provision for Type C meetings that seeks “FDA feedback on content of representative labeling for nonprescription drugs.” Requesters must now include a clear list of the meeting’s specific objectives or desired outcomes, and the guidance reinstates a recommended limit of ten questions, using a numbering system that assigns separate numbers to sub-questions. As with Type A and certain Type C sessions, the full meeting package must be submitted at the time the request is made for Type D and INTERACT meetings.
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Industry Feedback on Written Responses
BIO asked the agency to explain the criteria for deciding when a written response is appropriate. The guidance has not yet provided this information. The group noted that sponsors are increasingly choosing written responses over live sessions, even for complex topics.
Industry representatives said the lack of real-time clarification can be frustrating. They stated that face-to-face meetings allow for better probing of the agency’s thinking and valuable insight into program challenges.
