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Insights and Analysis

Drug research and development beyond earth’s gravity

Through Aerospace and Defense Insights, we share with you the top legal and political issues affecting the aerospace and defense (A&D) industry. Our A&D industry team monitors the...

Insights and Analysis

New SoHO Regulation published in the EU Official Journal

Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin intended for human application (SoHO Regulation) was yesterday published in the Official Journal...

News

Panelists discuss European pharmaceutical trends and how to stay ahead of the game

We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Zurich, where co-head of Hogan Lovells Life Sciences and Health Care sector Jane...

News

FDA publishes long-awaited clinical trial diversity guidance

The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations ...

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FDA publishes long-awaited clinical trial diversity guidance

The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations ...

News

Top legal issues to think about in China-related licensing transactions

This article provides a general overview of certain Chinese legal considerations for licensing and collaboration deals in the life sciences industry. In particular, this article focuses on...

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New transparency rules for EMA’s Clinical Trials Information System (CTIS)

As of 18 June 2024, the Revised CTIS Transparency Rules as adopted by the European Medicines Agency (EMA) apply, and will impact patients, health care professionals and sponsors. Also as of ...

Insights and Analysis

European Parliament Elections 2024: Explainer and Policy Takeaways

As the EU gears up for its upcoming elections, stakeholders across sectors are closely monitoring potential shifts in policy and governance. With an anticipated right-ward shift of the...

News

FDA Platform Technology Designation Program aims to speed development of drugs, biological products

The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, ...

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