Participate In Initial Industry-FDA Meetings

Find Sponsors

Pre-IND meetings are organized by industry/small business Sponsors of the investigational therapy. Because involvement of patient and patient groups in these types of meetings is still evolving, it is important to stay aware of the scheduling of any pre-IND meetings focused on treatments relevant to your disease to maximize the opportunity for input.

Maintain regular contact with academic and industry researchers focused on your disease.
Find other potential Industry Sponsors using the tips and resources provided in the NCATS Toolkit Getting Started: Build Relationships With Key Partners.

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)

Learn about Pre-IND Meetings

Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review U. S. Food and Drug Administration (FDA) (link)

Developing Products for Rare Diseases & Conditions U. S. Food and Drug Administration (FDA) (link)

Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting 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

Making Data Talk: A Workbook by the National Cancer Institute National Cancer Institute (NCI) (link)

FDA Patient Affairs U. S. Food and Drug Administration (FDA) (link)