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EU Emergency Response Update – Key Policy & Regulatory Developments No. 115

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

Vital Signs: Digital Health Law Update | Spring 2024

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

EU Emergency Response Update – Key Policy & Regulatory Developments No. 114

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

EU Emergency Response Update – Key Policy & Regulatory Developments No. 113

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

EU Emergency Response Update – Key Policy & Regulatory Developments No. 112

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

FDA's Final Device Manufacturing Rule—Not Quite Harmonious With Status Quo

Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more

Vital Signs: Digital Health Law Update | Winter 2024

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more

EU Emergency Response Update – Key Policy & Regulatory Developments No. 111

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

EU Emergency Response Update – Key Policy & Regulatory Developments No. 110

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

EU Emergency Response Update – Key Policy & Regulatory Developments No. 109

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

EU Emergency Response Update – Key Policy & Regulatory Developments No. 108

This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression against Ukraine, and cyber threats. It does not purport to provide an...more

Reversal of Burden of Proof Under Proposal for a New EU Product Liability Directive

In Short - The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more

EU Emergency Response Update – Key Policy & Regulatory Developments No. 107

This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression against Ukraine, and cyber threats. It does not purport to provide an...more

EU Emergency Response Update – Key Policy & Regulatory Developments No. 106

This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression against Ukraine, and cyber threats. It does not purport to provide an...more

EU Emergency Response Update - Key Policy & Regulatory Developments No. 105

This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression against Ukraine, and cyber threats. It does not purport to provide an...more

EU Emergency Response Update – Key Policy & Regulatory Developments No. 104

This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. It does not purport to provide...more

EU Emergency Response Update – Key Policy & Regulatory Developments No. 103

This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. ...more

EU Emergency Response Update – Key Policy & Regulatory Developments No. 102

This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. It does not purport to provide...more

EU Emergency Response Update – Key Policy & Regulatory Developments No. 101

This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. It does not purport to provide...more

EU Emergency Response Update – Key Policy & Regulatory Developments No. 100

This alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. It does not purport to provide an...more

COVID-19 Key EU Developments, Policy & Regulatory Update No. 99

This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. This COVID-19 Update...more

COVID-19 Key EU Developments, Policy & Regulatory Update No. 98

This regular update (no. 98 | 1 March 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more

COVID-19 Key EU Developments, Policy & Regulatory Update No. 97

This regular update (no. 97 | 14 February 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal...more

COVID-19 Key EU Developments, Policy & Regulatory Update No. 96

This regular update (no. 96 | 27 January 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more

EU Commission Proposes Extended Deadlines to Comply with the Medical Device Regulation and In Vitro Diagnostic Regulation

In Short - The Situation: The transition to the new so-called Medical Device Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR"), which establish new rules for the placing on the market of medical devices...more

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