> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Guide Updates Procedures for Formal Drug/Biologic Meetings
- URL: https://www.fdaweb.com/fda-guide-updates-procedures-for-formal-drug-biologic-meetings/
- Published: 2026-08-12T12:00:00.000Z
- Updated: 2026-09-14T13:44:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161618

FDA has issued updated guidance outlining procedures for formal meetings between the agency and sponsors or applicants developing or seeking approval for drugs and biological products. The document, [“Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products,”](https://www.fda.gov/media/172311/download?ref=fdaweb.com) describes standardized procedures for requesting, preparing, scheduling, conducting and documenting formal FDA meetings.

The guidance applies to formal meetings involving drug user fee-related products, including investigational new drug and biologics development programs and marketing applications. It does not apply to abbreviated new drug applications, biosimilar products or medical-device submissions. Meetings covered by the guidance can be conducted in person, virtually, by teleconference or through written responses in lieu of a meeting.

FDA continues to recognize six types of formal meetings under PDUFA: Type A, Type B, Type B end-of-phase, Type C, Type D and INTERACT meetings.

The guidance appears to place tighter boundaries around Type D meetings, which are intended for narrow issues requiring timely feedback. A Type D meeting generally should address no more than two focused topics and involve no more than three FDA disciplines or divisions. FDA may convert a request to a Type B or Type C meeting when the issues are broader or more complex.

INTERACT meetings are intended for novel drugs and biological products facing unique challenges during early development, particularly issues that could delay first-in-human testing. Topics can include novel nonclinical models, toxicology strategies, complex manufacturing processes, innovative drug-device technologies and New Approach Methodologies, FDA says.

The guidance establishes response and scheduling targets under the current user fee framework. FDA says it will respond to Type A and Type D meeting requests within 14 calendar days, Type B and Type C requests within 21 days, Type B end-of-phase requests within 14 days and INTERACT requests within 21 days.

The target for scheduling or providing a written response is 30 days for Type A, 60 days for Type B, 70 days for Type B end-of-phase, 75 days for Type C, 50 days for Type D and 75 days for INTERACT meetings.

FDA is advising sponsors to make meeting requests focused and to use existing agency guidance and other publicly available information before requesting meetings.

The agency generally recommends no more than 10 questions, including subquestions, in a meeting request. Questions should be organized by FDA discipline and accompanied by an explanation of their context and purpose.  
Meeting requests must include information such as the proposed meeting format, planned meeting-package date, purpose, background, proposed agenda, attendees, requested FDA participants and specific questions. Additional information includes the product name, proposed regulatory pathway, indication, meeting type and expected objectives or outcomes.

Sponsors must submit meeting packages according to meeting-specific deadlines, according to the guidance. It says meeting packages should be organized around the agenda and questions and should provide summarized, quantified data sufficient to support meaningful discussion. Full study reports and detailed protocols generally are not appropriate for the package.