# Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products:  Guidance for Industry - FDA Guidance Document

Source: 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

> FDA guidance document: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products:  Guidance for Industry. Issue date: June 27, 2015. Get complete insights and analysis.

---

## Details

- Title: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products:  Guidance for Industry
- 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: 2015-06-27
- Last Changed: 2020-02-10
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2013-D-0576">FDA-2013-D-0576</a>

## Related Documents

- [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)
- [Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/design-and-analysis-of-shedding-studies-for-virus-or-bacteria-based-gene-therapy-and-oncolytic-products-guidance-for-industry/d717cc69-a65f-4b33-94b8-cd9e6ff6f9c1)
- [Human Gene Therapy for Hemophilia:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/human-gene-therapy-for-hemophilia-guidance-for-industry/bceafce9-c9f0-4137-9ca5-071464212a06)
