Participate In Initial Industry-FDA Meetings

Learn about Pre-IND Meetings

A pre-IND meeting is a Type B FDA meeting which occurs early in the therapy development process to help to guide trial strategies. These meetings can help facilitate faster therapy approval processes. Pre-IND meetings greatly increase the likelihood of a program’s success by allowing concerns to be addressed early in the trial process. Pre-IND meetings are also a great opportunity to build a relationship with the FDA, minimize costs, and identify preclinical studies that have already been conducted. They are especially important when the therapy is intended to treat a serious or life-threatening disease.  

Note: A pre-IND meeting is for drug development. A pre-BLA meeting is for licensing of biologics. For device development, the process, when required  is called “pre-submission”, but is very similar. 

Resources

Overview
How to Study and Market Your Device U. S. Food and Drug Administration (FDA) (link)
The Device Development Process U. S. Food and Drug Administration (FDA) (link)
Prepare for the Meeting
Working with Regulators: A Focus on the FDA Cancer Policy Institute at the Cancer Support Community (link)
FDA Patient Affairs U. S. Food and Drug Administration (FDA) (link)
Biologics License Applications (BLA) Process (CBER) U. S. Food and Drug Administration (FDA) (link)
Target Product Profile Template Health and Human Services (HHS) ASPR (link)
The Target Product Profile Webinar Center for Biologics Evaluation and Research (CBER) Office of Cellular, Tissue and Gene Therapies (OCTGT) (link)
Tips for Success
FDA Patient Affairs U. S. Food and Drug Administration (FDA) (link)