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Hogan Lovells Publications

Podcast: Talking the cure

Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients. Over the next year, we will touch on cutting-edge topics such as...


FDA offers guidance on clinical trial waivers for investigators at non-U.S. sites

On May 19, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1),” updating ...


Life sciences and health care horizons 2021

Companies in the life sciences and health care industry navigated unparalleled challenges in 2020. The pandemic forced the development and adoption of new technologies and innovations...

Hogan Lovells Publications

Virtual health horizons 2020

As the world responds to the COVID-19 pandemic, physicians and patients are increasingly turning to virtual health solutions, including telehealth and remote monitoring, as a central facet...


Additional German guidance on the management of clinical trials during the COVID-19 pandemic

Further to the European Guidance on the Management of Clinical Trials during the COVID-19 pandemic, the German higher federal authorities (the Federal Institute for Medicinal Products and...

Hogan Lovells Publications

Digital health solutions in Germany: Detailed requirements for eligibility to reimbursement being fleshed out in draft legislation

In November 2019, the parliament passed a new law which will provide reimbursement for digital healthcare provision for the around 70 million publicly insured patients in Germany (Digital...

Hogan Lovells Publications

Early Access to Pharmaceutical Products in Major European Markets

The European Medicines Agency (EMA) has committed early patient access to new medicines, particularly those that target an unmet medical need or are of major public health interest.

Hogan Lovells Publications

Digital health solutions to become reimbursable in Germany – milestone for patients and providers

On 7 November 2019, the German parliament passed a new law enhancing digital healthcare provision for patients (Digital Health Service Act/Digitale-Versorgung-Gesetz – DVG). The focus ...

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