# Preclinical Assessment of Investigational Cellular and Gene Therapy Products: Guidance for Industry - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/preclinical-assessment-of-investigational-cellular-and-gene-therapy-products-guidance-for-industry/e4aedc4e-81e3-4d2e-b655-2460ccf3a04e > FDA guidance document: Preclinical Assessment of Investigational Cellular and Gene Therapy Products: Guidance for Industry. Issue date: November 01, 2013. Get complete insights and analysis. --- ## Details - Title: Preclinical Assessment of Investigational 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: 2013-11-01 - Last Changed: 2025-02-03 - Docket Number: FDA-2012-D-1038 ## Related Documents - [Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/current-good-tissue-practice-cgtp-and-additional-requirements-for-manufacturers-of-human-cells-tissues-and-cellular-and-tissue-based-products-hctps-guidance-for-industry/5197b518-94ba-4445-b2d4-cccf3c8ac0e9) - [Clinical Considerations for Therapeutic Cancer Vaccines: Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/clinical-considerations-for-therapeutic-cancer-vaccines-guidance-for-industry/e0e6e4e0-a883-4f71-bf37-784e147d32d9) - [Potency Tests for Cellular and Gene Therapy Products: Final Guidance for Industry:](https://www.globalkeysolutions.net/guidances/guidance-document/potency-tests-for-cellular-and-gene-therapy-products-final-guidance-for-industry/59c72aad-aad2-413a-82eb-440ea6bc25f8)