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  5. Expedited Investigational New Drug Pilot Program - Application Instructions
  1. FDA Expedited Investigational New Drug (IND) Pilot Program

Expedited Investigational New Drug Pilot Program - Application Instructions

Program Overview | Rolling Submission Process & Structure | Application Instructions

The application to the Expedited IND Pilot Program consists of the two forms below: 

  1. Sponsor and Investigational New Drug Information Form (PDF) to be completed by the sponsor 
  2. Prospective Research Institution Qualifications Form (PDF) to be completed by the prospective QRI

Applicants should download and complete the forms linked above. FDA asks sponsors to then submit the application forms for both themselves, and their prospective QRI, under a new submission via the FDA ESG Gateway, and will evaluate the submissions as a single package across the two entities. For additional information on how to apply to the pilot program, see: 

Parties are expected to form a business relationship external to the FDA. The FDA will not be involved in the oversight of the relationship during the pilot, other than confirming that an official agreement exists.  

The FDA plans to keep the application period open for 45 days, with the option to extend depending on the number of applications received. Applications will undergo review by FDA scientific experts, and FDA expects to select 8 to 10 Sponsor-QRI pairs to participate in the pilot. 

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