# IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/irb-review-of-stand-alone-hipaa-authorizations-under-fda-regulations-guidance-for-industry/8363a117-564d-4f47-9897-7aea13a1ef9f

> FDA guidance document: IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations:  Guidance for Industry. Issue date: August 16, 2003. Get complete insights and analysis.

---

## Details

- Title: IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: other
- Office Name: Office of the Commissioner
- Office URL: /offices/office-of-the-commissioner/79483979-9582-427f-ac3d-46c715811424
- Issue Date: 2003-08-16
- Last Changed: 2021-07-21
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2003-D-0037">FDA-2003-D-0037</a>

## Related Documents

- [Validation of Procedures for Processing of Human Tissues Intended for Transplantation:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/validation-of-procedures-for-processing-of-human-tissues-intended-for-transplantation-guidance-for-industry/098dfce7-8124-4658-98c8-d92a922f6766)
- [Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/determining-donor-eligibility-for-autologous-donors-of-blood-and-blood-components-intended-solely-for-autologous-use-compliance-policy-guidance-for-industry/66ca6a85-aebe-4b20-a0ba-d0f7e4e393d3)
- [Biological Product Deviation Reporting for Blood and Plasma Establishments:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/biological-product-deviation-reporting-for-blood-and-plasma-establishments-guidance-for-industry/6c58653c-8367-4da8-9b28-4e92356ee9c7)