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Published Works

Bad News for Device Sponsors: Panel Meetings were Already Going the Way of the Homework Assignment, and COVID Might "Put the Nail in the Coffin" Food and Drug Law Institute

Counsel Kristin Zielinski Duggan and associate Sandra Milena McCarthy co-authored an article published by the Food and Drug Law Institute.

Published Works

Implications of the one-year postponement of the application of the Medical Devices Regulation (MDR) LexisNexis

Life Sciences analysis: Regulation (EU) 2020/561 amends Regulation (EU) 2017/745, the Medical Devices Regulation (MDR) by postponing its application to 26 May 2021. Elisabethann Wright and...

Hogan Lovells Publications

Proposed measures in Germany for safeguarding supply of critical goods in the combat against COVID-19

In the wake of combating the COVID-19 pandemic, the German federal government is proposing to enable further measures on a federal level. The proposal includes important measures concerning ...

Hogan Lovells Publications

Highlights from the DigiHealth Leaders Conference: interoperability, reimbursement, patient centricity, and forging effective partnerships

Digital health offers huge potential for improving care and alleviating the increasing burden on our over-stretched healthcare systems. However, its uptake remains slow and varies...

Hogan Lovells Publications

DHSC Update on Medicines and Medical Devices Contingency Planning

Following the recent agreement to delay Brexit until 31 January 2020, the UK Department of Health and Social Care (DHSC) has written to suppliers of UK medicines and medical devices to...


De Novo requests: FDA releases updated RTA checklist Medical Device Alert

On 9 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled Acceptance Review for De Novo Classification Requests.

Hogan Lovells Publications

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program Health Alert

Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services...


Influencer Promo Guide: Best Practices for Drug and Device Firms

In our “Influencer promo guide: Best practices for drug and device firms”, we offered a list of best practices for medical device and pharmaceutical companies interested in...

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