The FDA has finalized new guidelines for meetings between the FDA and sponsors or applicants relating to the development and review of drugs or biological products under the Prescription Drug User Fee Act (PDUFA).
The FDA first published the draft guidance on Sept. 22, 2023, when it collected public comment on the guidelines. The final guidelines contain several changes from the draft, including modifying when INTERACT meetings are appropriate.
The draft guidance, which replaced the December 2017 version, added two new meeting categories, D and INTERACT.
The 2023 draft guidance introduced INTERACT meetings “intended for novel products and development programs that present unique challenges in early development (i.e., before filing of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 final guidance narrows the guidelines, stating that INTERACT meetings are “not the appropriate meeting type,” for requesters that have had a pre-IND meeting or filed an IND. This responds to Biotechnology Innovation Organization’s (BIO) comment on the draft guidance asking the FDA to clarify the difference between INTERACT meetings and pre-IND meetings.
The guidelines for Type D meetings remain consistent, with the final guidance providing three additional example scenarios.
The final guidance also states that the FDA can grant a written response only (WRO) instead of a live meeting for B (pre-IND), C, D and INTERACT meetings “regardless of format requested.” For other meeting types, the FDA can only substitute a WRO if the requester asks for one.
In its comment on the draft guidance, BIO “encourage[d] the FDA to outline the criteria applied in determining the appropriateness of WRO,” as “Industry Sponsors have experienced an increasing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 FDA has not provided the criteria requested.
In a white paper, BIO stated “when WRO responses are unclear, off-target or miss the intent of a question, the lack of opportunity for real-time clarification can be frustrating. Face-to-face meetings are more likely to provide opportunities to probe FDA’s thinking on relevant issues and obtain valuable insight into programmatic challenges.”
The final guidance adds pre-sNDA and pre-sBLA to Type B meetings. The document also adds seeking “FDA feedback on content of representative labeling for nonprescription drugs,” to Type C meetings.
The new guidelines also expand the requirements for meeting requests to include a list of the specific objectives or outcomes of the meeting, restored from the 2017 guidance after being dropped from the 2023 draft, and a recommended 10-question cap with a numbering convention where sub questions get their own number. Type D and INTERACT meetings, like Type A and some Type C meetings, require the meeting package at the time of request.
The new guidance does not apply to Abbreviated New Drug Applications (ANDAs), biosimilar applications or medical devices.
Filed Under: Regulatory affairs
