ARM facilitates constructive dialogue with regulators on key technical issues in cell and gene therapy, including gene editing, potency assays, and platform technologies. By reviewing best practices, sharing learnings, and fostering alignment, we work toward harmonized expectations across stakeholders. Our engagement spans the U.S. FDA, EMA, and other global regulators to support clear, consistent pathways for innovation and patient access.
ARM engages with the FDA through structured dialogue, industry perspectives in forums, and formal comments on draft guidance and requests for information.
ARM engages with the FDA through structured dialogue, industry perspectives in forums, and formal comments on draft guidance and requests for information.
ARM regularly comments on regulatory guidance, rules, and other policies that impact cell and gene therapy.
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