Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Follow us:



Sixth Circuit weighs in on meaning of causation, remuneration for False Claims based on alleged kickbacks

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...


New FDA electronic records guidance prioritizes Digital Health Technology oversight

On March 15, the U.S. Food and Drug Administration (FDA) issued revised draft guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical ...


After the Public Health Emergency: FDA plans to revise COVID-19 EUA policies

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Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will...


French CNIL is setting the tone for 2023: patients data and medical research on its radar

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...


FDA M-CERSI AI workshop highlights future FDA comment period on AI in drug development

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...


Strategic financial options for clinical stage life sciences companies in a troubled equity market

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...


CMS issues initial guidance on Drug Price Negotiation Program

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...


Agreement reached on new maritime biodiversity treaty

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”) ...


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...

Loading data