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2024
2023
2022
2021

Insights and Analysis

New SoHO Regulation published in the EU Official Journal

18 July 2024

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

Safe harbor for voluntary corrections of drug or device “misinformation” clarified in FDA guidance

17 July 2024

The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how...

News

Implications of the EU AI Act on medtech companies

16 July 2024

The European Union has introduced comprehensive regulations for artificial intelligence (AI) systems, encapsulated in the EU AI Act (AI Act). The objective of the AI Act is to ensure that...

News

Chevron’s demise brings promises & perils for life sciences companies

12 July 2024

The U.S. Supreme Court has issued its highly anticipated decision overturning the 40-year old doctrine established in Chevron v. Natural Resources Defense Council, which recognized judicial ...

News

Podcast: Talking the cure

12 July 2024

Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover...

News

Global impact of the EU AI Act for health stakeholders

10 July 2024

We recently hosted our 3rd annual AI Health Law & Policy Summit in Washington, DC where government and industry representatives joined members of the Hogan Lovells team to discuss new...

News

The increasing legalisation of French market access positions is confirmed

05 July 2024

The new amendments to the French framework agreement.

News

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

02 July 2024

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

29 June 2024

The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations ...

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© 2024 Hogan Lovells. All rights reserved. "Hogan Lovells" or the “firm” refers to the international legal practice that comprises Hogan Lovells International LLP, Hogan Lovells US LLP and their affiliated businesses, each of which is a separate legal entity. Attorney advertising. Prior results do not guarantee a similar outcome.