In September 2023, the FDA announced a new draft guidance, “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products,” which replaces the following guidance documents:

• Formal Meetings Between the FDA and Sponsors or Applicants (December 2017)
• Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (June 2018)

The new guidance provides recommendations for formal meetings conducted by industry sponsors or applicants with the FDA for the development of either drug or biological drug products and does not apply to abbreviated new drug applications, applications for biosimilar biological products, or medical devices. The updated recommendations detailed in the new draft guidance are as follows:

Addition of two new meeting types

The Type D meeting was added to facilitate discussion on a narrow set of issues that benefit from timely feedback (50 days from meeting request to either the meeting date or written responses). The Type D meeting is appropriate for discussions with no more than two focused topics, a limited list of questions, and that do not require input from more than three disciplines or divisions. When the preceding criteria is not met, a Type C meeting should be requested instead. The guidance also clarifies that it is not appropriate for a sponsor to request a series of Type D meetings in temporal proximity; in these instances, a Type C meeting should be requested. Rho has already supported several Type D meetings for topics ranging from nonclinical program issues to integrated statistical analyses. In each case, the meetings were limited to no more than two disciplines and were granted as either written response only (WRO) or as a virtual face‑to-face. Stay tuned for a future blog post discussing when a sponsor should request a Type D meeting versus a Type C meeting.

The Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs (INTERACT) meeting, a meeting type which has been available for CBER-regulated biologic drug products since June 2018, was expanded to include CDER-regulated products. The INTERACT meeting provides an opportunity for early discussion between the sponsor and FDA on novel products and development programs that present unique challenges during early development (e.g., before filing an IND or before a pre-IND meeting), with the goal of this meeting to facilitate IND-enabling efforts. The specific product or a product-derivation strategy must already be selected before requesting an INTERACT meeting. Official meeting minutes will not be provided; however, preliminary responses will be annotated and resent within 30 days if advice changes as a result of the meeting discussion. Rho has supported and facilitated several INTERACT meeting requests and meetings with both CDER and CBER. Based on our experiences working with sponsors and FDA on INTERACT meeting requests and meetings, Rho recommends that sponsors carefully consider the criteria detailed in the guidance to ensure that their product/program and the scope of the questions to be asked of the Agency will qualify for an INTERACT meeting and provide the rationale for why the request meets the criteria within the meeting request and briefing package (e.g., novel product type with no written FDA guidance, novel issue that prevents program from progressing forward with development, etc.). Even with a seemingly solid rationale, the FDA may reject an INTERACT meeting request if they believe it does not meet the criteria described in the guidance. In some cases, the FDA may deny the INTERACT meeting if they believe the program is more advanced in development and ready for a pre-IND meeting. In such situations, Rho recommends expanding upon the INTERACT request and briefing package for preparing the pre-IND materials.

For both Type D and INTERACT meetings, the meeting package is to be submitted at the same time as the meeting request, and, if the meeting is granted, the FDA will send preliminary written responses no later than 5 days before the meeting date.

Recategorization of meeting formats

The teleconference/videoconference format has been split into two discrete categories, resulting in four total meeting formats:

• In person face-to-face
• Virtual face-to-face (video conference)
• Teleconference
• WRO

Number of questions

Per the draft guidance, there should generally be no more than 10 total questions for the FDA at a single meeting. The FDA also requests that sub-questions are not submitted (e.g., 1a, 1b, 1c), as these will be counted towards the overall number of questions instead of a subset to a single question.

Process for formal follow-up/clarifying questions

For all meeting types, a formalized process has been introduced for sponsors to submit clarifying questions to the FDA; raising new issues or proposals is not appropriate for this process. To receive clarification, the sponsor is to submit a “Request for Clarification” to the FDA within 20 calendar days after the meeting minutes or WRO are received, and the FDA will respond within 20 calendar days.

If you are interested in further guidance on the preparation of Type D or INTERACT meeting materials, be sure to contact Rho!

Katherine Best, Ph.D., Regulatory Scientist, is an experienced Regulatory Scientist at Rho. She has 9 years of experience in writing and editing scientific documents and publications across a variety of scientific, clinical, and regulatory fields, which includes several publications in peer‑reviewed scientific journals. She has experience leading and managing regulatory and scientific authoring teams and has participated in the authoring and preparation of modules of regulatory submissions (IND, NDA, BLA, etc.), briefing packages to support regulatory meetings, clinical study protocols, informed consent documents, clinical study reports, and other regulatory documents. Dr. Best has experience across a variety of integrated product development projects in various phases of development, including early phase (pre‑INDs and INDs) and late phase submissions (NDAs and BLAs). Her therapeutic area experience includes, but is not limited to, orthopedics, pain, ophthalmology, oncology, and dermatology. Dr. Best received her Ph.D. in Pathology at the University of Rochester, where her research focused on fibrotic healing following acute musculoskeletal injury.  Prior to joining Rho, she was a clinical research scientist at Depuy Mitek. Dr. Best is a current member of the Regulatory Affairs Professionals Society (RAPS) and the American Medical Writers Association (AMWA).