Knowledge

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2024 Life Sciences & Health Care Horizons

While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent ...

News

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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U.S. device makers get 2 years to comply with FDA Quality Management System Regulations final rule

The U.S. Food and Drug Administration (FDA) published its long-awaited final rule to amend the Quality System Regulation’s (QSR’s) current good manufacturing practice (CGMP)...

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The “Borne Mission” Report analysis: Between hope and disappointment for the pharmaceutical industries

Borne's long-awaited Report on regulation of healthcare products has fallen well short of pharmaceutical industry expectations. Indeed, it contains very few concrete proposals.

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Supreme Court’s Schutte decision: the meaning of knowledge remains elusive

On June 1, 2023, the U.S. Supreme Court issued its highly anticipated opinion in the most watched False Claims Act (FCA) case in years.

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The next era of digital therapeutics

Products incorporating artificial intelligence/machine learning (AI/ML) algorithms have enormous potential for health care. The power of AI can enhance the capabilities of software that has ...

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Oral arguments suggest hesitancy from SCOTUS to agree with the Seventh Circuit on SuperValu FCA case

On April 18, 2023, the U.S. Supreme Court (SCOTUS) heard oral argument in the most significant False Claims Act (FCA) case to reach the Court in recent years. The Court is examining the...

News

The False Claims Act Guide: 2022 and the road ahead

In the latest edition of our False Claims Act Guide: 2022 and the road ahead, we analyze the key developments from 2022 and discuss how the most important cases and issues are shaping FCA...

News

After the Public Health Emergency: Implications for Medicare and U.S federal health care policies

On January 30, 2023, the Biden Administration announced that it intends to allow the COVID-19 national emergency and public health emergency (collectively, “PHE”) to expire...

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