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DOJ Bulk Data Final Rule Update

Today, the Department of Justice’s (“DOJ”) Final Rule implementing former President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by...more

FDA and OHRP Issue Draft Guidance on Including Biopsies in Clinical Trials

On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more

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