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Pathways to Approval: Recent Developments in EU Pharma and Medical Device Regulation

European Union, USA - December 26 2018 The contrast between the United States and European Union is no more apparent than when we consider the approach to centralized…

The New EU Regulation on Medical Devices Aims at Enhanced Product Safety and Further Harmonization

European Union, USA - May 9 2017 On May 5, 2017, the new Regulation on Medical Devices (MDR) and the new Regulation on In Vitro Diagnostics (IVDR) were published in the European…

Vernessa T. Pollard.

COVID-19 - Legal Implications for Pharmaceutical and Medical Device Companies in Germany

Germany - March 23 2020 The impact of Coronavirus (COVID-19) on pharmaceutical and medical device companies has been unique as, not only have these businesses had to set up…

Stephan Rau, Dr. Deniz Tschammler.

EC introduces major changes to medical device regulation

European Union - December 17 2012 The European Commission has issued two proposals that, if approved, will fundamentally amend EU law on medical devices and in vitro diagnostics.

Kristian A. Werling.

Fast Track for COVID-19 Drug and Vaccine Approval in the United States and Europe

European Union, USA - May 18 2020 The Coronavirus (COVID-19) pandemic poses an acute health risk to the population. One key to successfully combating COVID-19 lies in clinical…

Vernessa T. Pollard, Michael W. Ryan, Dr. Deniz Tschammler.