Hogan Lovells Publications

FDA guidances promote greater communication to payors about medical product value

On June 12, FDA finalized two guidance documents regarding the types of information that drug and device manufacturers may communicate to payors and that the agency regards as...

Hogan Lovells Publications

Paving the way for product authorization: FDA proposes rule to reclassify medical image analyzers

On June 4, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed order to reclassify certain software that analyzes medical imaging from class III (premarket...

Published Works

AHLA fundamentals of health law, seventh edition

A comprehensive resource for individuals who need to understand not only fundamental health law requirements, but also the complex web of legal relationships among patients, providers,...

Hogan Lovells Publications

New scientific data rules in China: China claims "data sovereignty"

In March of this year, the State Council released the Scientific Data Administrative Measures, a set of rules with the seemingly innocuous aim of collecting and making public the results of ...

Hogan Lovells Publications

FDA proposes streamlining combination product regulations

On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule...

Hogan Lovells Publications

A new right for American patients: The Right to Try

On May 22, 2018, the U.S. House of Representatives passed Senate Bill 204, commonly known as the “Right to Try Act of 2017” by a vote of 250-169. The bill gives certain patients ...

Hogan Lovells Publications

Patent law in Europe: What pharmaceutical companies need to know

With pharmaceutical competition in Europe continuing to evolve, established companies and new market entrants alike need to understand how key patent litigation tools are shaping the...

Hogan Lovells Publications

Administration presents plans to lower drug prices

On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the administration's plan to reduce...

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