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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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31 March 2023
The Sixth Circuit expanded the existing circuit split regarding when a kickback causes a federal health care claim to be false or fraudulent under the False Claims Act (FCA) and set out a...
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28 March 2023
On March 15, the U.S. Food and Drug Administration (FDA) issued revised draft guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical ...
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28 March 2023
On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will...
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27 March 2023
While the French Data Protection Authority (the "CNIL") has consistently emphasized the importance of protecting health data, there will be even more focus for 2023 with more...
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23 March 2023
The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently...
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23 March 2023
Early 2023 has seen new and unprecedented financial challenges for clinical stage life sciences companies. The financing rounds of 2021 and 2022 are starting to run off, while at the same...
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17 March 2023
On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Drug Price Negotiation Program, which was established under the Inflation Reduction...
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14 March 2023
After nearly two decades of on-off negotiations, agreement was reached on March 4, 2023 on a draft agreement under the United Nations Convention on the Law of the Sea (“UNCLOS”) ...
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14 March 2023
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...
