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OMB overhauls regulations for federal grants and cooperative agreements

The U.S. Office of Management and Budget (OMB) has released its long-awaited “Guidance for Federal Financial Assistance” to revise the regulations previously known as the OMB...

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FDA under fire: Pared-down LDT Final Rule leaves unanswered questions

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate...

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Fifth Circuit upholds injunction against borrower defense and closed school loan discharge rules

On April 4, 2024, the U.S. Court of Appeals for the Fifth Circuit ordered a federal district court to enter a nationwide preliminary injunction to enjoin the Department of Education (ED)...

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FDA and OHRP publish draft guidance on facilitating understanding in informed consent

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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Proof in Trial: University of Louisville

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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The False Claims Act Guide: 2023 and the road ahead

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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Biden Administration invites comments on new march-in rights framework

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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FDA webinar on speedy LDT rule finalization leaves key questions unanswered

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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Informed consent duties for IRBs, investigators, and sponsors detailed in FDA final guidance

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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