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DOJ Makes Significant Inflation Adjustment to Civil Monetary Penalties

Client Alert | less than 1 min read | 07.01.16

DOJ published an interim final rule on June 30, 2016, adjusting civil monetary penalties for inflation, that nearly doubles the prior penalty amounts under the Civil False Claims Act from the existing range of $5,500 - $11,000 to a new range of $10,781 - $21,563. The increased amounts, however, apply only to civil penalties assessed after August 1, 2016, for violations that occurred after November 2, 2015, while the penalty amounts for penalties assessed or for violations that occurred before these respective dates remain unchanged.

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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. ...

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