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COVID-19 Report for Life Sciences and Health Care Companies

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in...

Hogan Lovells Podcasts

FCA Podcast Series: 2020 and the road ahead Hogan Lovells

In addition to the False Claims Act Guide: 2020 and the road ahead, we are featuring a six-part podcast series based on select sections of the report. Go behind-the-scenes for more in-depth ...

News

Reforms to software-based medical devices take effect this week

The new classification rules for software-based medical devices (“SaMDs”) and personalised medical devices introduced by the Therapeutic Goods Legislation Amendment (2019...

News

The European Commission issues guidance concerning management of legacy devices in EUDAMED

On 15 February 2021, the European Commission published guidance on the Management of legacy devices in EUDAMED. This guidance addresses the registration and identification of legacy devices ...

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...

Hogan Lovells Publications

The False Claims Act Guide: 2020 and the road ahead Hogan Lovells

The pace of False Claims Act (FCA) litigation remained furious over the past year. Companies and individuals in all sectors of the economy continue to face the threat of FCA investigation,...

News

Increased use of virtual tools, optimized inspectional activities, & enhanced supply chain oversight

The COVID-19 pandemic has resulted in an unprecedented disruption to the U.S. Food and Drug Administration (FDA) inspection program. With the vast majority of its inspectional activities on ...

News

Biden Issues wide-ranging Buy American Executive Order – FAR rulemaking to come

On 25 January 2021, President Biden issued his first Buy American Executive Order (EO), titled Ensuring the Future Is Made in All of America by All of America’s Workers, which is...

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...

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