Publications

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...

Health care program penalties rise with Bipartisan Budget Act of 2018

Buried within a two-year budget agreement, among hundreds of pages of federal spending legislation, are key changes to several federal health care fraud statutes. The Bipartisan Budget Act...

Hogan Lovells Publications

China Drug Administration publishes a key Draft Guidance on data exclusivity for pharmaceuticals

This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with...

Hogan Lovells Publications

Parsing products: FDA regulatory policy for multi-function medical devices

On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's ...

Hogan Lovells Publications

FDA releases working model for Software Precertification Pilot Program

Last week, FDA released updates to its Software Precertification (Pre-Cert) Pilot Program, including release of a working model reflecting the Agency's vision of the pilot and outlining its ...

Published Works

The evolution of CBD in South Africa

During the past several decades, the advances made in the life sciences and health care industries have been astounding, not to mention revolutionary. A presently obscure and experimental...

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