Opportunity
Federal Register #FDA-2024-D-4311
FDA Guidance Release: Developing Cellular and Gene Therapy Products
Buyer
Food and Drug Administration
Posted
August 20, 2026
Identifier
FDA-2024-D-4311
The Food and Drug Administration (FDA), under the Department of Health and Human Services, has released a final guidance document for industry stakeholders developing cellular and gene therapy (CGT) products. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Purpose: - Provides answers to frequently asked questions about developing CGT products - Covers regulatory review, chemistry, manufacturing and controls (CMC), pharmacology/toxicology, clinical, and clinical pharmacology - Notable Details: - Guidance is intended to clarify development issues and support efficient product development - Finalizes a previous draft guidance - No procurement activity: - No OEMs, vendors, products, or services are requested - No quantities or part numbers specified - No unique technical or operational requirements beyond the scope of the guidance document
Description
The Food and Drug Administration (FDA) announces the availability of a final guidance document titled "Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products." This guidance provides industry with answers to frequently asked questions and addresses issues encountered during the development of cellular and gene therapy products. It covers multiple disciplines including regulatory review, chemistry, manufacturing, and controls (CMC), pharmacology/toxicology, clinical, and clinical pharmacology. The guidance finalizes the draft issued on November 19, 2024, and aims to support efficient development of these products by providing a repository of common questions and answers.