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Participate In Initial Industry-FDA Meetings

Securing an Invitation

FDA regulators are increasingly interested in having patients and patient group representatives participate in these early discussions, but the Sponsor is the one who will invite you to a pre-IND meeting. It is your job to make certain the Sponsor is aware of the benefits of your participation. Studies are often designed with hard data and statistical measures in mind, but this approach may not produce results that the patients and caregivers find valuable. Your participation in pre-IND meeting can ensure the FDA that the study objectives are designed with the needs of the patient community in mind.  

Participation by your group representatives in initial meetings between the Sponsor and the FDA can reduce therapy time to market by:

  • Ensuring that studies are designed to provide useful information.
  • Enhancing the understanding of data proposed to be gathered by clinical trial.
  • Providing a platform for the patient voice.
  • Creating or further growing a relationship between your group and the FDA.
  • Minimizing clinical holds on therapy development (an order issued by FDA to delay or suspend an ongoing trial/investigation).

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)