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EU Takes Next Steps to Address Medicinal Product and Medical Device Shortages

European Union - January 25 2022 Addressing medicinal product shortages has been high on the agenda of European Union (EU) and member state regulators for some time. January 25, 2022…

Anna-Shari Melin

EU Takes Concrete Steps to Facilitate Clinical Trials

European Union - January 24 2022 On January 13, 2022, the EU launched an initiative, ACT EU, that aims to transform and accelerate how clinical trials are initiated, designed, and…

Olivier Goarnisson, Josefine Sommer

Digitization of Instructions for Use: EU Adopts Awaited Implementing Regulation for eIFUs of Medical Devices

European Union - January 4 2022 On December 14, 2021, the European Commission adopted a new Implementing Regulation (EU) 2021/2226 for the use of electronic instructions for use…

Eva von Mühlenen, Josefine Sommer

Shortages of Medicinal Products Tackled by EU Regulators

European Union - November 8 2021 In a world reshaped by COVID-19, Brexit, and other major supply-affecting developments, EU regulators have put addressing economic disruptions due to…

Yuliya Gevrenova, Anna-Shari Melin

Anti-Corruption Quarterly Newsletter

USA - September 20 2021 On June 3, 2021, U.S. President Joe Biden issued a national security memorandum on “Establishing the Fight Against Corruption as a Core United States…

Ike Adams, Douglas A. Axel, Stephen L. Cohen, James M. Cole, Ellyce R. Cooper, Daniel C. Craig, Joseph R. Dosch, Craig Francis Dukin, Kevin M. Fee, Sara George, Jeffrey T. Green, Thomas C. Green, Shu Min Ho, David H. Hoffman, Mark D. Hopson, Joseph B. Tompkins Jr., Kristin Graham Koehler, Scott R. Lassar, Colleen M. Lauerman, Michael A Levy, Lei Li, Joan M. Loughnane, Geeta Malhotra, Michael D. Mann, Brian P. Morrissey, Ellen Crisham Pellegrini, Jack W. Pirozzolo, Karen A. Popp, Frank R.Volpe, Doreen M. Rachal, David M. Rody, Daniel D. Rubinstein, Leslie A. Shubert, Brian J. Stretch, Michele Tagliaferri, Yuet Ming Tham, Gordon D. Todd, Timothy J. Treanor, Angela M. Xenakis