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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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Publications

News

ASEAN Launches Model Contractual Clauses for Cross Border Data Transfers

On 22 January 2021 the Association of Southeast Asian Nations (ASEAN) Digital Ministers' Meeting approved the ASEAN Data Management Framework (the DMF) and the Model Contractual Clauses ...

News

Biotech & Digital Medicine Showcase: Life sciences firms advised on regulatory concerns, investing

Last week, Hogan Lovells partners Alice Valder Curran, Jodi K. Scott, and Jon Layman convened with other industry leaders virtually at this year’s Biotech and Digital Medicine...

News

2020 OPDP Wrap-up: FDA monitoring drug manufacturers’ use of online communication platforms

In 2020, the U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued four warning letters and two untitled letters to pharmaceutical companies for...

Hogan Lovells Publications

Podcast: Talking the cure

Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients. Over the next year, we will touch on cutting-edge topics such as...

News

New Orange & Purple Book laws increase transparency of patent information for drugs, biologics

On January 5, 2021, President Trump signed into law H.R. 1503, the "Orange Book Transparency Act of 2020," which amends provisions governing the types of patents and...

News

The EC publishes an inception impact assessment for the proposal of a European Health Data Space

The European Commission has published an inception impact assessment for a potential legislative proposal establishing a European Health Data Space. In its document, the European Commission ...

News

CJEU Advocate General reinforces the GDPR’s One Stop Shop

On 13 January 2021, the Advocate General (AG) of the Court of Justice of the European Union (CJEU) issued an important opinion in the case of Facebook Belgium v...

News

CMS finalizes “reasonable and necessary” definition, expedited breakthrough device coverage process

On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) published a final rule that, for the first time, adopts a regulatory standard for determining whether a ...

News

Five highlights from FDA’s new AI device regulation Action Plan

On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part...

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