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. 

• Understand the purpose of pre-IND meetings:
  • Identify supporting preclinical trials. 
    • A preclinical trial is a trial that tests the proposed therapy in animal or cell models. 
    • A preclinical study is required before clinical trials in humans can be started. 
    • By identifying these studies, you and the therapy Sponsor can gain access to feasibility, testing, and safety data that has already been generated.
  • Identify possible designations and development and review statuses that may accelerate or enhance the clinical trial or marketing review process. The FDA provides information about each of the available programs:
    • Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review  
    • Developing Products for Rare Diseases & Conditions
• Consider the main goals of a pre-IND meeting:
  • Reduce time to market.
  • Address novel qualities of application.
  • Provide guidance to industry/small business Sponsors new to process.
• Be aware of recurrent problems at pre-IND meetings, especially problems that your group may be able to address prior to the meeting. Identified problems include:
  • Inadequate chemical, manufacturing, and controls (CMC) information .
  • Insufficient preclinical support.
  • Unacceptable clinical trial design.
  • Noncompliance with Good Clinical Practices (GCPs ).
  • Lack of information on selection of dosage.
• Review the list of frequently asked questions the FDA has prepared for Sponsors about pre-IND meetings. Although written for small business and industry, the information answers many of the questions you may be asking as well: Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting (updated periodically).

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