# Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/determining-the-need-for-and-content-of-environmental-assessments-for-gene-therapies-vectored-vaccines-and-related-recombinant-viral-or-microbial-products-guidance-for-industry/7e121572-9573-4422-ac9b-6975e1e6dab6

> FDA guidance document: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products:  Guidance for Industry. Issue date: March 01, 2015. Get complete insights and analysis.

---

## Details

- Title: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial 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: 2015-03-01
- Last Changed: 2019-05-16
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2014-D-0663">FDA-2014-D-0663</a>

## Related Documents

- [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)
- [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)
