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European Commission Template Seeks to Further Harmonize Notified Bodies’ Clinical Evaluation Assessment of Medical Devices

USA - August 11 2020 In July 2020, the European Commission’s Medical Devices Coordination Group (MDCG) published a guidance document that endorses an annotated and...

Josefine Sommer, Anouchka Hoffmann, Yuliya Gevrenova.

Anti-Corruption: Quarterly - Q2 2020

USA - July 28 2020 On July 3, 2020, the U.S. Department of Justice (the DOJ) and the Securities and Exchange Commission (the SEC) jointly released the second edition of...

Michele Tagliaferri, Lei Li, Joseph B. Tompkins Jr., Zhengyu Tang, Stephen L. Cohen, Angela M. Xenakis, Timothy J. Treanor, Scott R. Lassar, Craig Francis Dukin, Brian J. Stretch, Chen Yang, Marc Palay, Kristin Graham Koehler, Yuet Ming Tham, Douglas A. Axel, Karen A. Popp, Leslie A. Shubert.

The New Pharmaceutical Strategy: Further Advances to Prevent Shortages in the EU

European Union - July 10 2020 The European Commission (Commission) is launching what it has branded the “new Pharmaceutical Strategy.” The overall goal of this strategy is to help...

Anna-Shari Melin.

EU Regulators Respond to COVID-19-Related Medicinal Product Shortages

European Union - May 20 2020 The COVID-19 pandemic has brought to the fore the fact that pharmaceutical companies with products on the EU market depend to a large extent on...

Anna-Shari Melin.

Postponement of Application of EU Medical Devices Regulation by One Year Confirmed

European Union - April 24 2020 On April 24, 2020, the EU legislator published an amendment to the EU Medical Devices Regulation (MDR) (Amending Regulation), postponing the...

Josefine Sommer, Anouchka Hoffmann.