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FDA has posted a draft guidance on BLA submission and postapproval management for individualized human genome editing products, with public comments due November 28, 2026.
Why it’s here: An FDA draft guidance open for public comment on regulating individualized genome editing therapies (BLA submission and postapproval management) is direct federal regulatory policy within biotechnology's cell and gene therapy scope.
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11:59 PMAgencyFDAFDA has posted a draft guidance on BLA submission and postapproval management for individualized human genome editing products, with public comments due November 28, 2026.Comment deadlineBiotechDetails
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- Food and Drug Administration