News & Analysis as of

International Trade Health

Read need-to-know updates, commentary, and analysis on International Trade issues written by leading professionals.

DOJ Announces Enhanced Enforcement of Healthcare FCPA Compliance

by Holland & Knight LLP on

The Department of Justice’s (DOJ) Criminal Fraud Section announced a new partnership between DOJ’s Healthcare Fraud Unit’s Corporate Strike Force and Foreign Corrupt Practices Act (FCPA) prosecutors. The partnership is meant...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

Building a sound strategy against false advertising claims in Europe

by Hogan Lovells on

Advertising is a major expenditure for pharmaceutical companies launching new products, but in the cutthroat European market, companies often try to gain competitive advantage by accusing competitors of engaging in false...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

EMA prepares plan to face Brexit

by Hogan Lovells on

European Medicines Agency (EMA) has released a business continuity plan dealing with the potential implications of Brexit. EMA, which is currently established in London, will be required to transfer the Agency’s headquarters...more

What’s New in Washington: 10 Things You Need to Know

The exuberance of a November election victory for Republicans has given way to the difficult reality of passing legislation in a closely divided Senate. While the GOP has made significant gains in the area of regulatory...more

A Difficult Decision for EMA

by Hogan Lovells on

The bids to host the EMA are in! We have reviewed all of them and give you our personal impressions on what to expect. After the EMA has announced the development of a business continuity plan to deal with the workload...more

Investigations in the Healthcare Sector by the French Competition Authority: Drugmakers’ Potential “Excessive Pricing” At Stake

by Reed Smith on

French competition authority to start investigations into potentially “excessive prices” in the healthcare market in the next weeks, following increasing scrutiny across Europe. On 3 July 2017, the president of the French...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

Dietary Supplement & Cosmetics Legal Bulletin | July 2017

JAMA Study and Editorial Call for Improvements in Cosmetic Regulation and Surveillance - In response to a study analyzing adverse events for cosmetics and personal care products, the Journal of the American Medical...more

What’s New in Washington: 10 Things You Need to Know

On June 30, Congress gaveled out for the July 4 recess after postponing a critical vote to begin debate on an Affordable Care Act (ACA) repeal-and-replace bill. Senate Majority Leader Mitch McConnell (R-KY) and the GOP caucus...more

Ministers Provide Insight on the UK's Position on the Regulation of Medicines post-Brexit

by Hogan Lovells on

With the negotiations for the UK’s withdrawal from the EU formally under way, the UK healthcare sector is calling on the UK Government to make patient safety and access to medicines a priority in negotiations – and it appears...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

676 Results
|
View per page
Page: of 28
Cybersecurity

Follow International Trade Updates on:

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.