PharmacovigilanceOfficial

CBER lists genome-editing BLA draft guidance and several approvals, blood policies in October updates

🇺🇸 FDA CBER · Tue 27 Oct 2026

FDA's biologics centre has posted a draft guidance on individualised genome-editing products, new blood donation compliance policies, immune globulin lot withdrawals and a run of approval documents.

FDA's Center for Biologics Evaluation and Research (CBER) updated its 'What's New for Biologics' page on 27 October 2026 with a draft guidance for industry on individualised human genome editing products. The document covers considerations for biologics licence application (BLA) submission and postapproval management. The page gives only the title, so the scope of those considerations is not detailed here.

Two compliance-policy guidances for industry on blood were posted on 14 October. One covers blood and blood component donation suitability, donor eligibility and Source Plasma quarantine hold requirements. The other addresses blood pressure and pulse donor eligibility requirements. On 21 October CBER also added recordings and a transcript from its roundtable on strengthening the supply chain for blood manufacturing.

On 8 October the centre listed voluntary lot withdrawals of intravenous (IGIV) and subcutaneous (IGSC) immune globulin products, linked to increased reports of allergic or hypersensitivity reactions. The entry does not name manufacturers or lots in the text available.

Approval documents were posted for several products. These include approval letters for VYJUVEK (21 October), EVARREST (16 October), NUWIQ (7 October), BIVIGAM and ASCENIV (both 29 September), ROTARIX (25 September) and ADZYNMA (23 September). For EVARREST, a clinical review memo dated 8 October and a statistical review dated 10 September were also added. A summary basis for regulatory action for FAYUVI, dated 17 September, was posted on 6 October.

CBER also updated internal procedures and reporting resources. Standard operating policies and procedures (SOPPs) listed cover PDUFA application payments (SOPP 8406), administrative processing of original BLAs and NDAs (8401), parallel scientific advice with the European Medicines Agency (8001.6), proper names and biological suffixes (8426) and regulatory meetings with sponsors (8101.1). Deviation reporting code lists for blood products, non-blood products and HCT/Ps were revised on 2 October.

What it means for your team

  • Sponsors of individualised genome-editing products should review the new draft guidance on BLA submission and postapproval management, and consider whether to comment.
  • Blood establishments and Source Plasma operators should check the two 14 October compliance-policy guidances against their donor eligibility and quarantine hold procedures.
  • Quality and pharmacovigilance teams handling immune globulins should review the lot withdrawal notice and any hypersensitivity reporting implications.
  • Regulatory affairs staff should check the updated SOPPs, including EMA parallel scientific advice, and the revised deviation reporting codes, for effects on submissions and reporting workflows.

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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