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Revealing the covert economics of licensing and collaborations: Technology transfers

Although upfront fees, milestones and royalties often take the spotlight in deal announcements in the life sciences sector, there exist numerous other cost allocation principles within...

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How to use a Data Monitoring Committee in clinical trials: FDA invites industry comment

Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring...

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Advances in Precision Medicine, the Future of Diagnostics, and FDA Priorities in an Election year

Speaking at the J.P. Morgan Healthcare Conference this year, Hogan Lovells life sciences regulatory partners Lowell Zeta and Blake Wilson, were joined by Greenleaf Health’s Kalah...

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FDA updates 2016 guidance on the collection of race and ethnicity data

The U.S. Food and Drug Administration (FDA) continues its efforts to include diverse participants in clinical research with a newly-published revision to its draft guidance document...

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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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FDA permits IRB informed consent waivers for minimal risk clinical trials

The U.S. Food and Drug Administration (FDA) has published a final rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical...

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Agencies issue guidance on delayed SEC reporting of material cybersecurity incidents

Since December 18, 2023 public companies other than smaller reporting companies are required to report a cybersecurity incident under Item 1.05 of Form 8-K within four business days after...

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FDA permits IRB informed consent waivers for minimal risk clinical trials

The U.S. Food and Drug Administration (FDA) has published a final rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical...

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JPM2024: Investing in preemptive medicine programs

An already challenging financing market can seem especially daunting for innovative technologies that seek to go beyond merely treating a disease in order to promote healthy longevity....

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