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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...

Insights and Analysis

MDR and IVDR: analysis of the Italian implementing Decrees

On 28 September 2022, Italian Legislative Decrees no. 137/2022 and 138/2022 entered into force. The two Legislative Decrees aim to adjust the Italian legal framework on medical devices to...

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The U.S. Food and Drug Administration (FDA) has published the revised draft guidance “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device...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

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

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...

Insights and Analysis

Proposal for a new Regulation on Substances of Human Origin (SoHO Regulation)
Registered Content

The newly proposed Regulation on Substances of Human Origin (“SoHO Regulation”) will give the EU legal framework on human blood, tissues, and cells a new shape. After almost 20...

News

Safety first: MHRA response to UK medical device regulation consultation

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to its consultation on the future regulation of medical devices in the United Kingdom which ran...

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

Panelists discuss present & future reimbursement mechanisms for AI health care products

At our recent Health Care AI Law and Policy Summit, Hogan Lovells partner Stuart Langbein moderated a panel discussion on AI policy and reimbursement issues. Joined by representatives from...

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