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# Cell/Gene Therapy Product Frequent Questions
- URL: https://www.fdaweb.com/cell-gene-therapy-product-frequent-questions/
- Published: 2024-11-19T12:00:00.000Z
- Updated: 2026-09-14T14:47:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158211

*Federal Register* notice: FDA is making available a draft guidance entitled “Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products.” The document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy products. The FAQs represent common questions related to multiple disciplines, including regulatory review, chemistry, manufacturing, and controls, pharmacology/toxicology, clinical, and clinical pharmacology. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-11-19/pdf/2024-26918.pdf?ref=fdaweb.com).