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FDA CBER lists new biologics guidances on gene editing, blood donation and potency assessment

🇺🇸 FDA CBER · Tue 27 Oct 2026

CBER's updated guidance page lists documents issued between July and October 2026, including a draft on individualised human genome editing products and blood donor compliance policies.

The FDA's Center for Biologics Evaluation and Research has updated its page of recently issued guidance documents, with content current as of 27 October 2026. The list covers CBER-led documents and cross-centre guidances issued from July to October 2026.

The most recent entries are dated October 2026. They include a draft guidance for industry on individualised human genome editing products, covering considerations for biologics licence application submission and postapproval management. Two blood-related compliance policies are also listed: one on blood pressure and pulse donor eligibility requirements, and one on blood and blood component donation suitability, donor eligibility and Source Plasma quarantine hold requirements.

September 2026 entries include final guidance for industry on developing blood collection, processing and storage systems for making blood components by the buffy coat method. A draft guidance from CDRH and CBER on an electronic submission template for premarket approval applications is also listed.

August 2026 items include final guidance with frequently asked questions on developing cellular and gene therapy products, and a draft on potency assessment of active immunotherapy products. A draft on container closure systems for human drugs and biological products, from CDER, CBER and OCP, is also listed, as is a final guidance from CDER and CBER on formal meetings between FDA and sponsors or applicants of PDUFA products.

July 2026 entries include a CDER/CBER draft on container closure systems and device constituent parts for biosimilar and interchangeable biosimilar products. Three final guidances on cancer clinical trial eligibility criteria are also listed, covering laboratory values, washout periods and concomitant medications, and performance status. The page notes that readers who find a broken link can search by document title or contact FDA.

What it means for your team

  • Regulatory teams working on cell and gene therapies should review the genome editing draft, the cellular and gene therapy FAQ and the potency assessment draft.
  • Blood establishment and plasma quality teams should check the October compliance policies on donor eligibility and Source Plasma quarantine hold requirements against current procedures.
  • Biosimilar and combination-product teams should look at the container closure drafts, including the one on device constituent parts.
  • The source gives only titles, centres and dates, so teams need to read the full documents to judge their impact and any comment deadlines.

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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