# FDA Launches Expedited IND Pilot

The U.S. Food and Drug Administration (FDA) has initiated an Expedited Investigational New Drug (IND) Pilot program in 2026 to accelerate the transition from drug identification to first-in-human clinical trials. This program facilitates partnerships between drug sponsors and qualified research institutions, aiming to reduce regulatory delays through rolling reviews and enhanced coordination. The FDA plans to select 8-10 sponsor-institution pairs, with applications open until October 30, 2026. This initiative presents new contracting opportunities for firms specializing in clinical trial support, regulatory consulting, and related services.

- The pilot program is managed by FDA centers including the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).
- Procurement professionals should note the application deadline of **October 30, 2026**, for participation in this pilot.
- Contractors offering expertise in clinical trial management, regulatory affairs, and data submission processes may find increased demand.
- This program reflects FDA's strategic emphasis on accelerating drug development timelines, potentially influencing future procurement priorities and contract solicitations.

**Jurisdictions:** federal
**Industries:** Healthcare
**Topics:** Regulatory Compliance
**Published:** September 16, 2026

### Government Entities
- U.S. Food and Drug Administration (FDA)
- U.S. Department of Health and Human Services (HHS)
- Center for Biologics Evaluation and Research (CBER)
- Center for Drug Evaluation and Research (CDER)

### Key Quotes
> The pilot not only pairs industry innovators with top research institutions to accelerate high-quality data being submitted to the FDA, it also tests if the partnership can accelerate what happens after the FDA allows a clinical trial to proceed.
> — Kyle Diamantas, Acting FDA Commissioner

### Sources
- [FDA Launches Expedited IND Pilot, Begins Accepting Applications | FDA](https://www.fda.gov/news-events/press-announcements/fda-launches-expedited-ind-pilot-begins-accepting-applications) - FDA