The FDA issued a draft guidance on November 18 titled “Frequently Asked Questions: Developing Potential Cellular and Gene Therapy Products.” This guidance aims to assist the industry by addressing FAQs and common challenges encountered during the development of cellular and gene therapy (CGT) products. Its purpose is to support the development of safe, effective, and high-quality CGT products.
The FAQs reflect common questions posed to the FDA by sponsors during development programs, inquiries following public presentations by FDA staff, and questions from public stakeholders via CBER. The guidance covers multiple disciplines, including regulatory review, chemistry, manufacturing and controls (CMC), pharmacology/toxicology, clinical considerations, and clinical pharmacology.
The FDA may update this guidance in the future to include additional FAQs as needed. Currently, this guidance is available for comment purposes only.
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