# 2026-12621: FDA Explores Faster Track for Early Drug Testing

2026-12621, Expedited Investigational New Drug Pilot Program; Request for Information, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-06-24, effective Either electronic or written comments, data, or information must be received by July 22, 2026.; PRIA reads it as touching household money (as of 2026-07-01).

- Canonical: https://policyrisk.com/federal-register/2026-12621
- As of: 2026-07-01
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-12621
- Title: Expedited Investigational New Drug Pilot Program; Request for Information
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 37996
- Published: 2026-06-24
- Effective: Either electronic or written comments, data, or information must be received by July 22, 2026.
- Comments close: 2026-07-22
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-07-01

## In one line

FDA Explores Faster Track for Early Drug Testing

## Summary

The FDA wants to speed up how fast new drugs get tested on people by creating a special pilot program. This program will team up trusted research groups with drug makers to review early study plans faster, while keeping safety top priority. If you’re involved in drug research or healthcare, now’s your chance to share ideas before July 22, 2026!

## Abstract

The Food and Drug Administration (FDA or the Agency) is opening a public docket to solicit input and comments on a proposal to establish a pilot program, the Expedited Investigational New Drug (IND) pilot program, to shorten the time it takes from drug identification to first-in-human (FIH) study, while protecting clinical trial participants. FDA is requesting information on the potential pilot program which would establish a network of qualified research institutions, such as academic medical centers (AMCs), healthcare networks (HNs), contract research organizations (CROs), regulatory advisors, and/or other research or third-party review organizations (collectively called Qualified Research Institutions, or "QRIs"), who would partner with sponsors to develop and review protocols for FIH clinical trials intended for a IND submission to FDA. Information provided through this public docket will help the Agency refine our approach and consider other opportunities to accelerate time to FIH clinical trials.

## Effects PRIA read

- Faster First‑in‑Human Trials: benefit, medium. FDA proposes a pilot to shorten the time from nonclinical research to first‑in‑human (FIH) studies by using qualified research institutions (QRIs), a rolling IND submission platform, and parallel activities like IRB review and site contracting. The pilot would allow FDA to review IND components on…
- Sponsors Pay QRIs Directly: cost, medium. The notice states that following the pilot, FDA expects sponsors will pay fees directly to Qualified Research Institutions (QRIs), and FDA will not set or collect those fees. Sponsors that participate should expect to pay QRIs for services after the pilot.
- FDA Keeps Final Decision Authority: benefit, low. FDA will limit QRIs to advisory roles and will remain solely responsible for regulatory decisions. FDA retains authority to issue clinical holds, disqualify investigators, disqualify or restrict IRBs or institutions, require safety reporting, and conduct inspections.

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## Sources
- [2026-12621 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/24/2026-12621/expedited-investigational-new-drug-pilot-program-request-for-information)
- [2026-12621 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-24/pdf/2026-12621.pdf)

## Related
- [Previous: 2026-12620, Master Protocols for Drug and Biological Product Development; Draft Guidance fo…](https://policyrisk.com/federal-register/2026-12620)
- [Next: 2026-12622, Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biologic…](https://policyrisk.com/federal-register/2026-12622)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-12621 (as of 2026-07-01).