ARM connects the FDA with the cell and gene therapy sector to help develop strong and innovative regulatory frameworks for a rapidly changing industry.
We work with the FDA’s Office of Therapeutic Products to share knowledge, update best practices, and evaluate the effectiveness of regulatory pathways.
ARM hosts periodic scientific exchanges with regulators to explore challenging topics, such as potency assay requirements and platform technologies.
ARM conducted a horizon scan to identify several groundbreaking approaches poised to shape the regulatory future of cell and gene therapy.
ARM is currently conducting a periodic ‘Lunch & Learn’ webinar series for FDA staff. Each webinar focuses on emerging technologies from our horizon scan.
ARM regularly comments on FDA regulatory guidance, rules, and other policies that impact cell and gene therapy.
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