# Federal Register #FDA-2026-N-4699

FDA Request for Information: Expedited IND Pilot Program for Clinical Trials

**Buyer:** Food and Drug Administration
**Posted:** June 24, 2026
**Respond By:** August 24, 2026
**Identifier:** FDA-2026-N-4699
**NAICS:** 541715, 541690

The Food and Drug Administration (FDA), under the Department of Health and Human Services, is seeking stakeholder input on a proposed Expedited Investigational New Drug (IND) Pilot Program.
- Government Buyer:
  - Department of Health and Human Services (HHS)
  - Food and Drug Administration (FDA)
- Purpose:
  - Request for information (RFI) regarding the design and implementation of a pilot program to accelerate the timeline from drug identification to first-in-human (FIH) clinical trials
- Program Details:
  - Establishment of a network of Qualified Research Institutions (QRIs), including academic medical centers, healthcare networks, contract research organizations, regulatory advisors, and third-party review organizations
  - QRIs will partner with sponsors to develop and review protocols for FIH clinical trials intended for IND submission
  - Pilot aims to improve IND submission quality, reduce FDA review time through rolling submissions, and accelerate clinical trial initiation
  - FDA will retain full regulatory authority and oversight
- Products/Services Requested:
  - No specific products, OEMs, or purchase quantities are requested
  - Solicitation is for information, comments, and recommendations from stakeholders on the pilot program's structure and requirements
- Unique Requirements:
  - Emphasis on collaboration between FDA, QRIs, and sponsors
  - Focus on maintaining participant safety while expediting clinical trial processes
  - Input sought on network structure, review processes, and implementation challenges

### Description

The Food and Drug Administration (FDA) is extending the comment period for a notice published on June 24, 2026, which opened a public docket to solicit input and comments on a proposal to establish a pilot program called the Expedited Investigational New Drug (IND) pilot program. This program aims to shorten the time from drug identification to first-in-human (FIH) study while ensuring the protection of clinical trial participants. The extension allows interested persons additional time to submit comments until August 24, 2026.

[View original listing](https://www.federalregister.gov/documents/2026/06/24/2026-12621/expedited-investigational-new-drug-pilot-program-request-for-information)