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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

HHS withdraws proposal to exempt 84 medical device types from FDA 510(k) process

On April 16, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) published a notice of withdrawal of their January 15 proposal to exempt 84 medical ...

Hogan Lovells Publications

Life sciences and health care horizons 2021

Companies in the life sciences and health care industry navigated unparalleled challenges in 2020. The pandemic forced the development and adoption of new technologies and innovations...

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

HHS proposal to exempt medical devices from 510(k) process halted

On January 15, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the...

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...

Media Mention

Bold predictions for medtech in 2021 MD+DI

Partners Mike Heyl and Jodi Scott were quoted in MD+DI's "Bold predictions for medtech in 2021."

News

Looking ahead to 2021: AI – A brave new world?

In recent years, AI has become a buzzword in life sciences and health care as the technology has developed to create applications from drug discovery to diagnostics to therapeutics. Most...

News

FDA proposes clarification in long-running tussle over “intended use” rules for drugs and devices

On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when...

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