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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.
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11 March 2024
As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research...
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20 February 2024
What happens when an NCAA college basketball program is enmeshed in a NCAA investigation accusing them of using boosters to pay for the best recruits? In the case of the Louisville...
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14 February 2024
In the latest edition of our False Claims Act Guide: 2023 and the road ahead, we analyze the key developments from 2023 and discuss how the most important cases and issues are shaping FCA...
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21 December 2023
On Friday, December 8, the U.S. Department of Commerce's National Institute of Standards and Technology (NIST) opened for public comment its Draft Interagency Guidance Framework for...
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14 December 2023
The U.S. Food and Drug Administration (FDA) signaled that it intends to finalize its laboratory developed test (LDT) proposed rule by April 2024. The new rule (if finalized as...
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02 November 2023
Nine years after the draft version was published, the Food and Drug Administration (FDA) has finalized its guidance on informed consent for sponsors, institutions, IRBs, and investigators....
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11 October 2023
Last week, the U.S. Department of Health and Human Services (HHS) Office of Research Integrity (ORI) made the announcement many academic institutions, legal professionals, and observers in...
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05 October 2023
In a landmark proposed rule published Friday, the U.S. Food and Drug Administration (FDA) announced plans to make explicit that in vitro diagnostic products (IVDs), including in cases where ...
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04 October 2023
In a landmark proposed rule published Friday, the U.S. Food and Drug Administration (FDA) announced plans to make explicit that in vitro diagnostic products (IVDs), including in cases where ...
