Arnold & Porter
On 7 April 2020, the European Medicines Agency (EMA) issued a Notice to sponsors on validation and qualification of computerised systems used in clinical trials (Notice).
New innovations include connected remote monitoring devices, patient engagement tools, Artificial Intelligence (AI)-based automated detection and diagnosis, and smart operating rooms.
The Minister of Health, Dr Aaron Motsoaledi (Minister), has been entrusted with the unenviable
task of overseeing South Africa's transition to universal health coverage
In a welcome move, on 1 April 2019 the U.S. Food and Drug Administration (FDA) proposed reducing regulatory requirements for a number of radiation-emitting electronic products.
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars.
On April 9, 2018, the Centers for Medicare & Medicaid Services (CMS) released the Benefit and Payment Parameters final rule for 2019 (2019 Payment Notice) applicable to qualified health plans (QHPs) ...
Van Bael & Bellis
On 7 March 2016, the Government submitted to the Chamber of Representatives a bill on the counterfeiting of medical products and similar crimes involving threats to public health.
On February 25, the Belgian Privacy Commission published an opinion (source document in French) on cloud computing in a hospital setting...
In Europa zouden al zeven miljoen rokers de klassieke sigaret gedeeltelijk of volledig hebben ingeruild voor haar elektronische tegenhanger.
The medical devices sector covers a wide range of products, from simple bandages to highly sophisticated devices such as pacemakers, as well as contact lenses, prostheses, medical equipment for hospital use, etc.
The COVID-19 crisis is first and foremost a health issue, as governments around the world seek to limit and treat its effects and save lives. However, it is also an immediate economic and...
Cleary Gottlieb Steen & Hamilton LLP
The Commission also recalls that ill-designed national restrictions can exacerbate problems and contribute to amplifying shortages in other Member.
Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients.
The European Medicines Agency (EMA) has committed early patient access to new medicines, particularly those that target an unmet medical need or are of major public health interest.
Shortly after updating the related draft Questions and Answers document, the European Commission has published two new...
Nctm Studio Legale
This article is based on a presentation made to the Montreal/Statale University 2018 Summer School in bilateral trade relations between the EU and North America, given on 28 May in Montreal Canada.
Van Bael & Bellis
Under Article 4 of the Directive, a person injured by a defective product should prove the damage, the defect and the causal relationship between defect and damage.
Van Bael & Bellis
On 28 January 2015, in two separate decisions, the European Commission conditionally approved a complex transaction between pharmaceuticals producers GlaxoSmithKline (GSK) and Novartis.
Implementing legislation to enact the United States-Mexico-Canada Agreement (USMCA) is expected to be introduced as early as the week of 16 December following extensive discussions...
In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs