Overview
Pre-IND meetings are formal meetings or official written correspondence between the FDA and investigators who seek advice relating to the development and review of investigational new drugs and biologics (INDs). Pre-IND meetings can increase the likelihood of a successful IND application, or help to address clinical holds due to FDA safety concerns with an IND application.
Resources
FDA Guidance:
- Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry external site (opens in a new window) (December 2017)
- Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting external site (opens in a new window)
- Pre-IND Consultation Contacts external site (opens in a new window) for Center for Drug Evaluation and Research (CDER)
UCSF Templates:
UCSF Resources: