# Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure:  Guidance for Institutional Review Boards and Clinical Investigators - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/protection-of-human-subjects-categories-of-research-that-may-be-reviewed-by-the-institutional-review-board-irb-through-an-expedited-review-procedure-guidance-for-institutional-review-boards-and-clinical-investigators/3f36bd8c-c7f3-43b6-8b85-5e6e92984169

> FDA guidance document: Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure:  Guidance for Institutional Review Boards and Clinical Investigators. Issue date: November 09, 1998. Get complete insights and analysis.

---

## Details

- Title: Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure:  Guidance for Institutional Review Boards and Clinical Investigators
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Office of the Commissioner
- Office URL: /offices/office-of-the-commissioner/79483979-9582-427f-ac3d-46c715811424
- Issue Date: 1998-11-09
- Comment Close Date: 1998-03-10
- Last Changed: 2023-03-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1997-N-0257">FDA-1997-N-0257</a>

## Related Documents

- [Variations in Drug Products that May Be Included in a Single ANDA](https://www.globalkeysolutions.net/guidances/guidance-document/variations-in-drug-products-that-may-be-included-in-a-single-anda/ce22de7a-f17d-437d-bcd0-2ab5803add37)
- [Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products:   Guidance for IRBs and Clinical Investigators](https://www.globalkeysolutions.net/guidances/guidance-document/institutional-review-board-irb-review-of-individual-patient-expanded-access-submissions-for-investigational-drugs-and-biological-products-guidance-for-irbs-and-clinical-investigators/d18c103b-b568-496d-a0f1-6c8fa7abdd67)
- [S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing)](https://www.globalkeysolutions.net/guidances/guidance-document/s4a-duration-of-chronic-toxicity-testing-in-animals-rodent-and-nonrodent-toxicity-testing/274c345e-d541-42de-a26c-85fefde1aa9e)