Chemistry, Manufacturing, and Controls– tag –
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FDA Releases Draft Guidance to Streamline Gene Therapy Development, Aiming to Accelerate Access to Novel Therapies
BioProcess International USA Overview The FDA has issued draft guidance for gene therapy development, designed to streamline the process by enabling developers to leverage prior knowledge and platform data. This non-binding document from... -
FDA Issues New Draft Guidance to Accelerate Cell and Gene Therapy Development: Promoting Efficiency Through Prior Knowledge Utilization
FDA Press Announcements USA Overview The FDA announced new draft guidance on June 2, 2026, aimed at accelerating the development of cell and gene therapies. This guidance encourages sponsors to effectively leverage 'prior knowledge,' par... -
FDA Finalizes Guidance on CMC Flexibility for Cell and Gene Therapies, Expediting Access to Advanced Treatments
Regulatory Focus USA Overview The U.S. FDA has issued final guidance outlining flexible Chemistry, Manufacturing, and Controls (CMC) requirements for cell and gene therapy (CGT) products, recognizing their inherent complexities compared ...
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