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Research security program guidelines: more work for federally-funded research institutions

The White House Office of Science and Technology Policy (OSTP) has issued long-awaited Guidelines for Research Security Programs at Covered Institutions (“Guidelines”), which...

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What the proposed House settlement means for NCAA Division I institutions

On May 23, 2024, the NCAA and the five autonomy conferences — known colloquially as the “Power Five” — agreed to terms for a $2.78 billion settlement to resolve...

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Recent developments in FCA enforcement under the DOJ’s Civil Cyber-Fraud Initiative

Over the last six months, the U.S. Department of Justice (DOJ) has remained vigilant in pursuing cybersecurity-related fraud under its Civil Cyber-Fraud Initiative first announced in...

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FDA and OHRP publish draft guidance on facilitating understanding in informed consent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