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

The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how...


Implications of the EU AI Act on medtech companies

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...


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

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 ...


Podcast: Talking the cure

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...


Global impact of the EU AI Act for health stakeholders

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...


The increasing legalisation of French market access positions is confirmed

The new amendments to the French framework agreement.


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...


Tortoise and Hare: Congress may overtake CMS in years-long race to set Medicare breakthrough device coverage

On June 27, 2024, the Ensuring Access to Breakthrough Products Act of 2024 (H.R. 1691) was marked up and reported out of the House Ways and Means Committee. This action brings Medicare...


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The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations ...

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