IND Application Procedures: Interactions with FDA
Sponsors of IND applications may obtain advice and guidance from FDA at any stage of IND development. A sponsor may consult with the Agency before formal submission of an IND application and send a pre-IND meeting request (PDF - 145KB) to an appropriate Review Division responsible for overseeing products in the therapeutic area relevant to the IND application
A pre-IND meeting may be requested for issues related to data needed to support the rationale for testing a drug in humans; the design of nonclinical pharmacology and toxicology studies including design and potential uses of any proposed treatment in animal models; data requirements for an Investigational New Drug (IND) application; initial drug development plans, regulatory requirements for demonstrating safety and efficacy and other aspects of the development program.
Sponsors of IND applications may request formal face-to-face meetings (PDF - 95KB) that can be scheduled throughout the development program.
Other interactions with FDA may occur via a variety of communication means including written correspondences, submission of IND Application Amendments, Dispute Resolutions, and e-mail and telecommunications with project management staff in the appropriate Review Division.
Sponsors of IND applications should recognize that investigational new drug product development is the sponsor’s responsibility. FDA can provide regulatory advice and oversight as needed and will do its best in granting meeting requests; however, the Agency may not be able to grant all meeting requests due to resource limitations and competing priorities.
Additional FDA Guidance documents related to interactions with FDA are listed below.
FDA Guidances Related to Interactions with FDA
- Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants
- Guidance for Industry: IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Control
- Guidance for Industry: End-of-Phase 2A Meetings
- Guidance for Industry and Review Staff: Formal Dispute Resolution: Appeals Above the Division Level