Participate In Initial Industry-FDA Meetings

Overview

Talk to the Sponsor about participating in their early meetings with the U.S. Food and Drug Administration (FDA). In most circumstances, before an Industry Sponsor can administer an investigational therapy to humans, they must submit an Investigational New Drug (IND) Application to request authorization from FDA to transport or distribute the investigational therapy across state lines. The Sponsor may request pre-IND meetings with FDA to request feedback on their development program. FDA regulators are increasingly interested in having patients and patient advocates participate in these early discussions. However, it is up to the Industry Sponsor to invite patient groups to participate because the FDA cannot invite patients or patient advocates directly. 

  • The biologics license application (BLA) is similar to the IND application and is used by Sponsors for investigational biologics. Pre-BLA meetings with the FDA have similar goals as pre-IND. 
  • The FDA approval of medical devices prior to marketing the device is very dependent on the classification of the device and is not addressed specifically in this section. To learn more about the medical device marketing approval process, you may wish to reference FDA: How to Study and Market Your Device , which is written for small business and industry Sponsors, and FDA: The Device Development Process , which is written for patients.

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)