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The Global Investigations Review Guide to Compliance

Client Alert | 1 min read | 08.12.24

As the primary civil enforcement statute for investigating and remedying fraud in connection with United States government programs, the False Claims Act (FCA) has resulted in more than $75 billion in recoveries of government funds since 1986. The FCA imposes liability on any person or entity that knowingly submits false claims or certifications to the government or improperly retains money owed to the U.S. government.

In this first-ever chapter on the False Claims Act published by the Global Investigations Review Guide to Compliance, Crowell attorneys provide an informed practical explanation of the requirements of the FCA for both U.S. and international companies and institutions. The chapter describes issues that arise in the investigation and litigation process, as well as common theories of liability in two industries that continue to be targets for FCA actions: government contracts and healthcare.

Insights

Client Alert | 7 min read | 09.14.26

AI in Life Sciences: Ten Legal Considerations and Risks of AI Use in Drug Discovery and Development

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage. ...