U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
- Direct communication occurs rarely and only under the following circumstances:
- Prior supervisory approval is acquired
- FDA review team member has documented a memorandum in the IND file
- FDA management decides communication is allowed (on a case-by-case basis and not by the IND sponsor)
FDA-Sponsor Interactions During Drug Development
Page 5 of 7
