# Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture:  Final Guidance - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/changes-to-an-approved-application-biological-products-human-blood-and-blood-components-intended-for-transfusion-or-for-further-manufacture-final-guidance/d3ff905e-6a8a-440f-bdde-3f125c0e2af2

> FDA guidance document: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture:  Final Guidance. Issue date: December 01, 2014. Get complete insights and analysis.

---

## Details

- Title: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture:  Final Guidance
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Biologics Evaluation and Research
- Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d
- Issue Date: 2014-12-01
- Last Changed: 2019-08-22
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1999-D-3528">FDA-1999-D-3528</a>

## Related Documents

- [Considerations for the Development of Dried Plasma Products Intended for Transfusion:   Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/considerations-for-the-development-of-dried-plasma-products-intended-for-transfusion-guidance-for-industry/c0c693ab-7392-4bad-b4c9-de122a24ced4)
- [Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/considerations-for-the-design-of-early-phase-clinical-trials-of-cellular-and-gene-therapy-products-guidance-for-industry/58006e15-498f-4ae9-a7c8-6112a8210c55)
- [Recommendations for Microbial Vectors Used for Gene Therapy:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/recommendations-for-microbial-vectors-used-for-gene-therapy-guidance-for-industry/bdeabfdf-bbbe-4b57-a5be-ef92ff0cf1bd)
