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FDA's draft guidance on potency assessment for active immunotherapy products is open for public comment under docket FDA-2026-D-8561 until November 19, 2026.

Why it’s here: An FDA draft guidance on potency assessment for active immunotherapy products is a federal regulatory action in the biotechnology area (FDA regulation of novel therapies), with an open public comment period, making it relevant to DC policy readers.

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FDA's draft guidance on potency assessment for active immunotherapy products is open for public comment under docket FDA-2026-D-8561 until November 19, 2026. — The Wave