# Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products: Guidance for Industry - FDA Guidance Document Source: 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 > FDA guidance document: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products: Guidance for Industry. Issue date: August 27, 2015. Get complete insights and analysis. --- ## Details - Title: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic 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: 2015-08-27 - Last Changed: 2019-05-16 - Docket Number: FDA-2014-D-0852 ## Related Documents - [Long Term Follow-up After Administration of Human Gene Therapy Products: Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/long-term-follow-up-after-administration-of-human-gene-therapy-products-guidance-for-industry/5f3e0db9-8c8a-45b5-864f-6250a3250b1b) - [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)