Knowledge

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Follow us:

Publications

News

FDA invites comments on xenotransplantation product regulatory standards ahead of public meeting

On June 29-30, 2022, the U.S. Food and Drug Administration (FDA) will hold a virtual public meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) to discuss its...

News

FDA spells out electromagnetic compatibility info needed in medical device premarket submissions

The U.S. Food and Drug Administration (FDA) recently issued the final guidance, “Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug...

Insights

UK Real Estate Life Sciences: what are the issues facing landlords, developers and investors?
Registered Content

Over the last eighteen months we have seen more and more landlords, developers and investors looking at opportunities to invest in the UK life sciences sector. As with any new and...

News

Unapproved stem cell therapies remains a top FDA enforcement priority

Speaking Tuesday at the Food and Drug Law Institute (FDLI) Annual Conference, Mark Raza, FDA Chief Counsel, discussed the investigations priorities for FDA’s Office of the Chief...

News

The new Clinical Trials Regulation – what you need to know now

With this series we provide insights on what you need to know now about the new EU Clinical Trials Regulation (“CT Regulation”).Episode 4: Protection of vulnerable groupsThis...

News

Emerging AI issues affecting EU, UK life sciences firms

At our recent Health Care AI Law and Policy Summit, Hogan Lovells attorneys Dan Whitehead, Bonella Ramsay, Louise Crawford, and Imogen Ireland convened with industry leaders virtually at...

News

Evolution of FDA regulation of AI-based technology

Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in...

News

Public life sciences companies uniquely positioned as SOX retaliation defendants

Sarbanes-Oxley’s (SOX) whistleblower protections can create tricky issues for public life sciences and health care companies. Consider taking steps now to help mitigate these risks.

News

Key legal concerns for advanced therapy medicinal product (ATMP) sponsors in Europe

In recent years we have seen more and more gene and cell therapies coming successfully to market – but many more such candidates have not made it to market, or been unable to obtain...

Loading data