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
- Request Submission: 60-90 days before desired date
- FDA Acknowledgment: Within 21 days
- Briefing Document: Submitted 30 days before meeting
- Preliminary Response: FDA provides 5 days before meeting
- Meeting: In-person, teleconference, or written response
- 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