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The European Parliament formally adopted the EU Artificial Intelligence Act (AI Act), a first-of-its-kind comprehensive regulation governing the use of artificial intelligence (AI), on March 13, 2024. While applicable to a...more
On December 8, 2023, EU policymakers reached an agreement on the Artificial Intelligence Act (AI Act). As a standard-bearer for global digital and data governance, the EU has been setting regulatory benchmarks on emerging...more
In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will significantly impact...more
On July 18, 2022, the UK government published high-level proposals for its approach to regulating uses of artificial intelligence (AI), as part of its National AI Strategy and, more broadly, its UK Digital Strategy. The...more
On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand....more
The European Commission today announced that it is preparing a proposal to postpone the entry into application of the new Medical Devices Regulation (MDR). The proposed postponement would be for one year....more
On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices....more
It's been a year since the European Commission published its Fifth Report on the application of the European Product Liability Directive (the "Directive") and set up expert panels to develop its thinking on next policy steps....more
On 23 January, the European Commission announced that it had adopted an adequacy decision in relation to Japan, to enter into force immediately. The mutual agreement, which covers Japan’s 127m citizens as well as the whole of...more
The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to provide hospitals, clinics, ministries and competent authorities...more
Introduction The European Commission has published a factsheet addressed to competent authorities of third countries....more
On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic...more
The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively....more
On 9 August 2018, the European Commission published five new documents intended to provide guidance to manufacturers concerning the implementation of the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical...more
The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders....more
The European Commission is looking into several parallel imports cases, including in the life sciences industry, with a view to opening formal antitrust investigations, which may eventually lead to fines being imposed....more
On 28 March 2018, the European Commission’s (EC) Directorate-General for Communications Networks, Content and Technology released an important notice to stakeholders (the “Notice”) on the impact of Brexit on. ...more
The European Commission has adopted a “New Deal for Consumers” package which aims to empower consumers, promote fairness and build trust across the single market. ...more
The Competent Authorities for Medical Devices (“CAMD”) has published a roadmap concerning the implementation of the Medical Devices Regulation (“MDR”) and In Vitro Diagnostic Regulation (“IVDR”). The roadmap has been prepared...more