# 2025-19984: FDA Updates Rules for Accessing Trial Drugs in Crises

2025-19984, Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry; Availability, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-11-17, effective 2025-11-17 (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-19984
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-19984
- Title: Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry; Availability
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 51369
- Published: 2025-11-17
- Effective: 2025-11-17
- Comments close: not stated
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Updates Rules for Accessing Trial Drugs in Crises

## Summary

The FDA just released new, easy-to-understand rules about how patients can get access to experimental drugs when no other treatments work. This update affects doctors, drug makers, and patients by clarifying the process and replacing old guidance from 1998. The new rules are effective starting November 17, 2025, and aim to speed up access without extra costs or delays.

## Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers." This guidance finalizes the revised draft guidance issued on November 2, 2022, and replaces the final guidance of the same title issued in June 2016 and updated in October 2017. The guidance addresses frequently asked questions, including those related to the implementation of FDA's regulations on expanded access to investigational drugs and other topics related to expanded access that are promulgated through the 21st Century Cures Act (Cures Act) and the FDA Reauthorization Act of 2017 (FDARA). Upon publication of this guidance, FDA is withdrawing the 1998 information sheet guidance, entitled "Emergency Use of an Investigational Drug or Biologic," for institutional review boards and clinical investigators because the information provided in the 1998 guidance is included in this final guidance.

## Effects PRIA read

- Final FDA Expanded Access Guidance: benefit, medium. The FDA published final guidance titled "Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers" on November 17, 2025. It finalizes the November 2, 2022 draft and replaces the 2016/2017 guidance, clarifying how patients and doctors can pursue access to investigational dru…
- Manufacturers Must Publish Access Policies: benefit, low. Under section 561A of the FD&C Act (as amended by the Cures Act) and FDARA, a manufacturer or distributor must make its expanded access policy readily available to the public (for example, by posting it on a website). The policy must be posted by the earlier of the first initiation of a phase 2 or…
- Clarified Consent and Submission Steps: benefit, medium. The final guidance includes additional clarifications related to informed consent and the process for submission of expanded access requests. Those clarifications were added between the November 2022 draft and this final guidance and take effect with the guidance announced on November 17, 2025.

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## Sources
- [2025-19984 on federalregister.gov](https://www.federalregister.gov/documents/2025/11/17/2025-19984/expanded-access-to-investigational-drugs-for-treatment-use-questions-and-answers-guidance-for)
- [2025-19984 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-11-17/pdf/2025-19984.pdf)

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- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-19984 (as of 2026-06-08).