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Unlike acne vulgaris, HS is a distinct condition with unique symptoms and treatment approaches

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However, industry engagement may depend on how trials conducted by such consortia fit into the overall development program and timeline for drug candidates and whether the studies will be supportive for regulatory submission and approval (NASEM, 2024)

The applicant stated that assigning the nominated device to C1763, C1765, or C1781 would not only be inappropriate from a descriptive standpoint but would also fail to facilitate tracking of the device's utilization and outcomes since its use would be obscured under codes that include many other dissimilar products

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