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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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Publications

Hogan Lovells Publications

Podcast series: False Claims Act 2019 and the road ahead Hogan Lovells

In addition to the False Claims Act Guide: 2019 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 ...

Insights

Germany is going to specify safety expectations for reimbursable digital health applications
Registered Content

Last month, Germany introduced the Digital Health Service Act, which grants German patients access to reimbursable digital health applications.In order to establish the procedural...

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...

Insights

Federal Circuit Acetris decision changes procurement country of origin landscape
Registered Content

On Monday, in the much-anticipated decision in Acetris Health, LLC v. U.S. 18-2399, the Court of Appeals for the Federal Circuit (the “Federal Circuit”) ruled that U.S....

Insights

OIG clears manufacturer-sponsored travel and lodging support in limited circumstances
Registered Content

The latest advisory opinion published by the U.S. Department of Health and Human Services Office of the Inspector General (HHS OIG) approves one pharmaceutical manufacturer’s travel...

Insights

“Misleading” to suggest a biosimilar is inferior, FDA draft guidance warns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to advance biologics competition, the U.S. Food and Drug Administration (FDA) on February 3 published a 10-page Q&A draft guidance, “Promotional...

Insights

CMS’ 2021 health insurance exchanges proposal shifts pharmaceutical manufacturer copay coupon policy
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On January 1, 2020, the Centers for Medicare & Medicaid Services (CMS) released the proposed Notice of Benefit and Payment Parameters for 2021 (“2021 NBPP Proposed Rule”),...

Published Works

Applying FDA's Rules in the new World of Online Marketing and Crowdfunding Regulatory Affairs Professionals Society

Suzanne Levy Friedman authored "Applying FDA's Rules in the new World of Online Marketing and Crowdfunding" that originally appeared inRAPSRegulatory Focus.

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 ...

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