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2024 Life Sciences & Health Care Horizons

While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent ...

News

FDA AI & Medical Products Paper advocates for a tailored risk-based regulatory framework

The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and...

News

Marked Safe from Cyber Threats: FCC Launches New IoT Labeling Program

The Federal Communications Commission (FCC) unanimously approved a Report and Order (R&O) creating a new voluntary Cybersecurity Labeling Program for Internet of Things (IoT) products....

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

BIOSECURE Act aims to restrict funding and genetic data use by foreign adversary biotech companies

The BIOSECURE Act (the “Act”), introduced by members of the House Select Committee on the Strategic Competition between the United States and the Chinese Communist Party...

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...

Insights and Analysis

Webinar: Data protection in the Middle East and Africa feat. Nigerian Data Protection Commissioner

The "new normal" of global data protection regulation is becoming increasingly complex. With 37 African countries having a comprehensive data protection legal framework and the...

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

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...

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