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“Misleading” to suggest a biosimilar is inferior, FDA draft guidance warns
Registered Content

As part of its continuing efforts to advance biologics competition, the U.S. Food and Drug Administration (FDA) on February 3 published a 10-page Q&A draft guidance, “Promotional...

Hogan Lovells Publications

The Future of Mining | Diversity

After what can be described as a difficult period for mining, many are predicting that the mining sector is experiencing a renaissance and nowhere is this welcomed more than on the...

Insights

2019 OPDP enforcement letters target how drug risk information is conveyed in promotional materials
Registered Content

In 2019, the U.S. Food and Drug Administration's ("FDA" or "the Agency") Office of Prescription Drug Promotion (OPDP) issued three warning and seven untitled letters ...

Insights

U.S. + Germany patent update – January 2020 (한국어)
Registered Content

Hogan Lovells’ U.S. + German Patent Update reports on recent patent news and cases from the United States and Germany, and is available in English, Korean, and Japanese.

Insights

U.S. + Germany patent update – January 2020 (English)
Registered Content

Hogan Lovells’ U.S. + German Patent Update reports on recent patent news and cases from the United States and Germany, and is available in English, Korean, and Japanese.

News

Welcoming new IPMT partners and counsel in 2020

We are delighted to announceour new Intellectual Property, Media & Technology (IPMT) partners and counsel. The promoted members of the IPMT practice span patents, trademarks,...

News

Revised ISO 14971 Application of Risk Management to Medical Devices released

ISO 14971:2019 Medical devices – Application of risk management to medical devices is a new update on the 2013 version of this global standard.

Hogan Lovells Publications

FCA Alert: Decision Opens Door to Challenge of Agency Guidance in False Claims Cases FCA Alert

On November 5, 2019, the United States District Court for the Eastern District of Pennsylvania ruled on a motion to dismiss a False Claims Act (FCA) qui tam suit filed by the United States...

News

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.

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