On September 22, 2023, the FDA unveiled its draft guidance document, “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products”.
Scope and Applicability:
This guidance provides recommendations to industry on formal meetings between the FDA and sponsors or applicants of drug or biological products that are regulated by Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), respectively, but not to generic drugs, biosimilars, or medical devices. The guidance defines formal meetings as any meeting that emphasizes on good meeting management practices.
The updated guidance, which replaces the December 2017 version, introduces two new meeting types: Type D and Initial Targeted Engagement for Regulatory Advice (INTERACT), along with four existing formal meetings (Type A, Type B, Type B (end of phase (EOP)), and Type C). It also presents a new “virtual face-to-face” video conference meeting format, supplementing the existing options of joining face-to-face meetings, teleconferences and written response only (WRO).
About Type D Meeting:
A Type D meeting is for discussing a narrow set of issues critical to advancing a program
- These meetings usually involve 1 to 2 issues and their associated questions.
- They should be limited to no more than 2 focused topics and should not require input from more than 3 disciplines or divisions.
- If there are more than 2 focused topics or complex single issues with multiple questions, a Type C meeting is more suitable and should be requested instead of a Type D meeting.
- Examples and scenarios where Type D meetings may be appropriate include questions about complex or innovative trial design or presenting data following a pre-BLA/NDA meeting or a specific follow-up question from a Type C meeting.
- The agency must respond to requests for Type D meetings within 14 days and schedule a meeting within 50 days of the request.
About INTERACT Meeting:
- The INTERACT meetings are designed for novel products and development programs facing unique challenges in early development, typically related to IND requirements, complex manufacturing technologies, innovative devices, and New Approach Methodologies. INTERACT meetings facilitate IND-enabling efforts, when novel and challenging issues might hinder progress towards clinical trials. Sponsors should have a specific investigational product or a strategy chosen before requesting such a meeting.
- Topics covered in INTERACT meetings include questions and issues that lack existing guidance or reference materials from the FDA. These may involve selecting appropriate preclinical models, addressing chemistry, manufacturing, and controls, providing advice on safety/biodistribution studies, making recommendations for first-in-human trials, and guiding further development of early-stage products with limited data. Other topics can also be discussed by agreement with the FDA.
- FDA must respond to requests for INTERACT meetings within 21 days and schedule a meeting within 75 days of the request.