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For CY 2026, we are revising 410.27(a)(1)(iv)(B)( 1 ) and 410.28(e)(2)(iii) to make the availability of the direct supervision of CR, ICR, PR services and diagnostic services via audio-video real-time communications technology (excluding audio-only) permanent, except for diagnostic services that have a global period indicator of 010 or 090

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This process, often referred to as target validation , is a foundational step in early drug development