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FDA CBER cell and gene therapy guidance list adds genome editing BLA draft

🇺🇸 FDA CBER · Tue 27 Oct 2026

CBER's guidance listing for cellular and gene therapy products shows seven 2026 entries, the latest a draft on individualized genome editing products dated October 2026.

The FDA's Center for Biologics Evaluation and Research (CBER) maintains a page listing its cellular and gene therapy guidance documents by year. The most recent entry is a draft guidance for industry dated October 2026: "Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management".

The page shows six other 2026 entries. In August 2026 it lists a final guidance, "Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products", and a draft on potency assessment of active immunotherapy products. June 2026 brings a draft on leveraging prior knowledge in developing gene therapy products that incorporate genome editing. May 2026 is a guidance on chemistry, manufacturing and controls flexibilities for cellular and gene therapy products going to a biologics license application.

The remaining 2026 items are drafts. An April 2026 draft covers safety assessment of genome editing using next-generation sequencing. A February 2026 draft covers the plausible mechanism framework for individualized therapies targeting specific genetic conditions with a known biological cause.

The page also carries September 2025 drafts on postapproval methods to capture safety and efficacy data, innovative trial designs for small populations, and safety testing of expanded human allogeneic cells. It lists older documents too, including the January 2024 genome editing guidance, the CAR T guidance, and guidance on long-term follow-up and manufacturing comparability. The listing does not say which drafts are open for comment or give any other detail, so teams should check each document on the FDA site.

What it means for your team

  • Genome editing is a clear focus of the 2026 listings, spanning BLA submission, postapproval management, prior knowledge and sequencing-based safety assessment. Teams with editing programmes should read the relevant drafts.
  • Most 2026 entries are labelled drafts, so their content may change. Check each document's status and any comment deadlines on the FDA page before building them into plans.
  • CMC and potency teams should look at the May 2026 CMC flexibilities guidance and the August 2026 draft on potency assessment of active immunotherapy products.

Official source: FDA CBER ↗

Article written by VigiEye from the official source (FDA CBER). AI-assisted; check the source before acting.

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