# Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products:   Guidance for IRBs and Clinical Investigators - FDA Guidance Document

Source: 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

> FDA 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. Issue date: September 11, 2023. Get complete insights and analysis.

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## Details

- Title: Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products:   Guidance for IRBs and Clinical Investigators
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2023-09-11
- Last Changed: 2023-09-11
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-3452">FDA-2023-D-3452</a>

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