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Netherlands Adopts US FDA-based UDI System for Medical Devices

by Knobbe Martens on

A voluntary agreement (link in Dutch) was consummated by the Dutch Ministry of Health, industry, and hospitals. According to an Emergo blog post, under the terms of the agreement, the Netherlands will adopt the US Food and...more

EMA Updates Guidance Concerning Medicinal Products Intended Exclusively For Non-EU Countries

by Hogan Lovells on

The European Medicines Agency (“EMA”) has updated its guidance (Guidance) regarding procedural advice for medicinal products intended exclusively for markets outside the European Union (“EU”). The Guidance addresses several...more

Drones Delivering Medical Supplies in East Africa but not in U.S.

Residents in remote areas of Tanzania and Rwanda in East Africa are receiving medical supplies through the use of drones, far surpassing similar efforts in the U.S., according to Robert Graboyes, a senior research fellow at...more

General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part Three)

Even though the GDPR is a general regulation, some provisions are expressly addressing the specificities of the processing of personal data in the healthcare/life science sectors....more

General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part One)

The clock is ticking: on May 25, 2018, in less than a year from now, the General Data Protection Regulation (“the GDPR”) will apply in all Member States of the European Union (“EU”) and will replace the Directive 95/46/CE...more

General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part Two)

New General Features of the GDPR - Some of the GDPR general features may be of particular interest for companies in the healthcare/life science sectors....more

FDA Announces Import Staffing Change at International Mail Facilities

Earlier this month, The Washington Post reported that Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that he was reallocating three dozen employees to international mail facilities (IMF), as well as...more

Human Germline Genome Editing – Genetics bodies weigh in on debate with position paper

by Allen & Overy LLP on

In an article published in American Journal of Human Genetics on 3 August 2017, an international group of 11 organisations with genetics expertise has issued a joint position statement, setting out 3 key positions on the...more

Healthcare Industry May Not Be Prepared For Internet of Things

by Knobbe Martens on

A recent survey conducted by ZingBox, a Silicon Valley internet security startup, found that more than 90% of healthcare IT networks have Internet of Things (IoT) devices. The survey further found that more than 70% of IT...more

News from Abroad -- Briefing on Supplementary Protection Certificates for Medicinal Products

What are SPCs? A Supplementary Protection Certificate (SPC) is an intellectual property right available for active ingredients of human and veterinary medicinal products requiring marketing authorisation. Originally...more

Approved Biosimilar Products Around The world

Please see full chart below for approved biosimilar products around the world. ...more

Biosimilars in Europe

Europe has led the way globally with respect to biosimilar medicines since 2005. In that year, the European Medicines Agency (EMA) issued regulatory guidelines for the development and assessment of biosimilars....more

Journal of Nanobiotechnology Publishes Special Issue on Swiss National Research Program on the “Opportunities and Risks of...

by Bergeson & Campbell, P.C. on

The Journal of Nanobiotechnology published a special issue on the outcome of Switzerland’s five-year National Research Program on the “Opportunities and Risks of Nanomaterials” (NRP 64). The editorial states that the...more

New UK Brexit Health Alliance Formed

by Hogan Lovells on

A “Brexit Health Alliance” (BHA) has been formed to bring together a diverse range of UK stakeholders in the healthcare industry and provide a single voice for the sector on Brexit-related issues. Members of the BHA include...more

EMA Calls for Public Consultation on Clinical Trial Protocol, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

June 2017 The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014)...more

EMA Green Lights New EudraVigilance System for Adverse Reactions, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

On May 22, 2017, the European Medicines Agency ("EMA") announced the full functionality of the new EudraVigilance system for the collection and monitoring of suspected adverse reactions with medicinal products that are...more

Senators Urge the Administration to Certify Imports of Prescription Drugs from Canada, Pharmaceutical & Medical Device Update,...

by Jones Day on

On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of...more

Guidance for European MA Holders to Prepare for Brexit, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

The EMA has published a Q&A guidance for marketing authorization ("MA") holders of centrally authorized medicinal products to prepare for the United Kingdom's withdrawal from the European Union. This follows an earlier notice...more

EU Medical Device Regulation 2017/745 and In Vitro Diagnostic Regulation 2017/746, Pharmaceutical & Medical Device Update, Vol....

by Jones Day on

Following their adoption by the European Parliament in April 2017, the final versions of the Medical Devices Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR") were published in the Official Journal of the...more

Rx IP Update - June 2017

by Smart & Biggar on

Supreme Court of Canada News - SCC denies Apotex leave to appeal omeprazole infringement decision. On June 1, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal (docket no. 37478) the Federal Court...more

OFAC Enforcement Trends in the Health Care, Agriculture and Tech Industries

by Baker Donelson on

The United States Department of the Treasury's Office of Foreign Assets Control (OFAC), the U.S. governmental agency tasked with administering and enforcing economic sanctions against hostile targets in furtherance of U.S....more

Unfair and Unbalanced-Episode 20, Roy's Retirement Announcement Edition

by Thomas Fox on

In this episode, I visit with Roy Snell about his recent announcement that he is stepping down as head of the SCCE. We review the current state of the SCCE and how the Roy has seen the compliance evolve from its start after...more

Update on Regulatory Compliance in the Global Health Care Industry

by Baker Ober Health Law on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

All or Nothing at All: Brexit Update for Life Sciences Companies

by Arnall Golden Gregory LLP on

A lot of ink has been spilled in projecting what Brexit (the UK’s withdrawal from the European Union) might look like, including in this space by this author. The simple fact is that we don’t know what Brexit will actually...more

“Fireball” Malware a Threat to Health Care Industry

A new report released by Check Point has security personnel working in the health care industry particularly concerned and they are warning their colleagues about the existence of “Fireball.”...more

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