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Payback and Health Technology Assessment in Italy: a new governance for medical devices?

While waiting for a new governance to make the process of selecting and purchasing medical devices more efficient, thus incentivizing investment in innovative technologies, the activation...

Insights and Analysis

Life Science Law Update – Key developments for pharma and device companies in EU and EU Big Five

In this first issue of our quarterly Life Science Law Update, our teams highlight key trends across life sciences regulatory, corporate, compliance, competition, and privacy throughout the...

News

FDA expands inspection obstruction guidance to apply to device facilities

The U.S. Food and Drug Administration (FDA) has published the revised draft guidance “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device...

News

Modernization of U.S. cosmetics regulation will be phased in over time

On December 29, 2022, U.S. President Biden signed into law the "Consolidated Appropriations Act, 2023," which includes the Modernization of Cosmetics Regulation Act of 2022...

News

UK MHRA delays new medical devices legislation until July 2024

The United Kingdom medical devices regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has announced that the upcoming changes to UK medical device legislation will...

News

FDA delays UDI database enforcement for low-risk devices

On July 25, 2022, the U.S. Food and Drug Administration (FDA) issued final guidance on Unique Device Identification (UDI) compliance date policies, stating that the agency will not enforce...

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World Stem Cell Summit panel compares global trends in regenerative medicine regulations

Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation, Hogan Lovells partners Mike Druckman, Ernesto Algaba, Mandi Jacobson, Lu Zhou, Mikael Salmela, Charlott...

News

Panelists sum up state of health care AI regulation, standards, and data challenges

At our recent Health Care AI Law and Policy Summit, Hogan Lovells partner Melissa Bianchi moderated a panel discussion on the state of the health care AI industry. Joined by representatives ...

News

Italian Sunshine Act and transparency in the health sector

From June 26th, 2022, the “Italian Sunshine Act” entered into force. This is a piece of legislation aimed at preventing corruption and fostering transparency in the health...

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