Institutional review board (IRB) review of individual patient expanded access submissions for investigational drugs and biological products: guidance for IRBs and clinical investigators
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Food and Drug Administration. Office of Clinical Policy. issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body. Oncology Center of Excellence (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biological Products Compassionate Use Trials Drug Industry Drugs, Investigational Ethics Committees, Research Government Regulation United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- This guidance provides recommendations to institutional review boards (IRBs) and clinical investigators regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions, including for reviews conducted by a single member of the IRB, to fulfill its obligations under 21 CFR part 56. Although FDA has issued guidance on expanded access requests, including expanded access for individual patients, the Agency is aware that IRBs seek further clarity on this topic. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (5 pages))
- NLM Unique ID:
- 9918716788206676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918716788206676