Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products

Issue Date: August 20, 2026
Issued by: Center for Biologics Evaluation and Research
Topic(s): Biologics, Gene Therapy
Status: Final

Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products

This final guidance provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products, spanning regulatory review, chemistry, manufacturing, and controls (CMC), pharmacology/toxicology, clinical, and clinical pharmacology topics. This guidance finalizes the draft version issued in November 2024 as part of FDA’s PDUFA VII commitment to support cellular and gene therapy product development.

Download the Guidance Document

webmaster2026-08-24T15:28:13+00:00

ABOUT US

Avance Biosciences is a leading Contract Research Organization (CRO) and Contract Testing Organization (CTO) providing CGMP and GLP-compliant analytical and bioanalytical services to support drug development. From early discovery through clinical development and commercialization, we provide CGMP and GLP-compliant services tailored to your therapeutic modality and regulatory needs.