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Device makers must verify third-party lab data, FDA warns

On Tuesday, the U.S. Food and Drug Administration (FDA) issued a letter warning medical device manufacturers and sponsors of device studies to carefully evaluate the third parties that they ...

News

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Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring...

News

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...

News

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(FDA) continues its efforts to include diverse participants in clinical research with a newly-published revision to its draft guidance document...

News

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...

News

U.S. device makers get 2 years to comply with FDA Quality Management System Regulations final rule

The U.S. Food and Drug Administration (FDA) published its long-awaited final rule to amend the Quality System Regulation’s (QSR’s) current good manufacturing practice (CGMP)...

Insights and Analysis

Life Science Law Update – Key developments for pharma & device companies in EU and EU Big Five
Registered Content

In this Q4/23 issue of our Life Science and Health Care Law Update, our teams highlight key trends across life sciences regulatory, corporate, compliance, competition, and privacy...

News

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...

News

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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