What is a Pre-IND Meeting?

Definition

Pre-IND Meeting is a formal consultation between drug sponsors and FDA that occurs before submission of an Investigational New Drug application. This Type B meeting helps sponsors understand FDA expectations and optimize their development strategy before committing to clinical trials.

How Pre-IND Meetings Work

Sponsors submit a meeting request with a briefing document containing specific questions. FDA responds with preliminary feedback, and the meeting provides opportunity for clarification and alignment.

Key Components

• Formal meeting request with proposed agenda
• Briefing document (submitted 30 days before meeting)
• Specific questions for FDA consideration
• Review of preclinical data package adequacy
• Discussion of proposed Phase 1 trial design

Pre-IND Meeting Process

1. Request Submission: 60-90 days before desired date
2. FDA Acknowledgment: Within 21 days
3. Briefing Document: Submitted 30 days before meeting
4. Preliminary Response: FDA provides 5 days before meeting
5. Meeting: In-person, teleconference, or written response
6. Minutes: FDA issues official minutes within 30 days

Why BD Teams Track Pre-IND Meetings

For business development professionals, Pre-IND interactions signal program maturity:

• Deal Implication: Positive Pre-IND feedback reduces regulatory risk and enhances asset value for licensing
• Due Diligence Focus: Request copies of FDA meeting minutes to assess regulatory alignment
• Opportunity Signal: Companies actively engaging FDA early demonstrate sophisticated regulatory strategy