Publications

Hogan Lovells Publications

A further step towards an EU-wide collective action Newsflash

Today representatives of EU member states agreed on a mutual position regarding the Commission's Proposal for a Directive on representative actions for the protection of the collective...

Hogan Lovells Publications

FDA delays draft rule for QSR/ISO 13485 harmonization Medical Device Alert

The U.S. Food and Drug Administration (FDA) indicated that the long-anticipated proposed rule modernizing the Quality System Regulation (QSR) is now targeted for release in April 2020.

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

Data class actions guide

Does your processing of personal data fall within the scope of the GDPR? Are you ready to defend potential data-related litigation – in particular, data class actions?

Hogan Lovells Publications

Appealing a denial of a drug/medical device export certificate: FDA final guidance Medical Device Alert

Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign...

Hogan Lovells Publications

CMS Innovation Center seeks input on Oncology Care Model sequel Health Alert

In a late-night announcement on Friday, 1 November, the Center for Medicare and Medicaid Innovation (CMMI) gave cancer providers the first look at a possible sequel to the Oncology Care...

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...

Hogan Lovells Publications

Complementary Medicines: the way forward

According to a recent report published by Grand View Research, Inc., it is expected that by 2026, the global complementary and alternative medicine (CAM) industry will generate over USD 200 ...

Hogan Lovells Publications

International Products Law Review 2019: Issue 75.

We are excited to bring you the latest issue of our International Products Law Review with insights and updates on all aspects of products law. In this issue, we explore the trustworthiness ...

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