1.6 — Meetings

Meeting requests and minutes for pre-IND, pre-NDA/BLA, and Type A/B/C meetings

Requirements by Phase

IND Phase 1: optional IND Phase 2: optional IND Phase 3: optional NDA: required

Content Requirements

• Pre-IND meeting requests with proposed agenda and questions
• Pre-NDA/BLA meeting requests
• Type A meeting requests (critical path issues, dispute resolution)
• Type B meeting requests (pre-IND, pre-NDA, mid-cycle)
• Type C meeting requests (other meetings)
• Briefing documents with background, data summaries, and specific questions
• Meeting minutes and agreed-upon action items

Expected Deliverables

• Meeting request letter
• Briefing document
• Meeting minutes

ICH Guidelines: FDA Guidance on Formal Meetings Between FDA and Sponsors

Source: FDA Formal Meetings Guidance