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Review of International Regulation of Social Media Promotions at the 2016 RAPS Conference

The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the...more

Addressing Zika’s Continued Threat to the Workplace

The growing prevalence of the Zika virus in the United States has already presented a number of hurdles for employers striving to create a safe and healthy workplace environment for their employees. These concerns are more...more

Hackers Post Athletes’ Medical and Drug Testing Records Online

Hacking group Fancy Bear, reportedly a Russian group, who allegedly hacked into the Democratic National Committee emails which made headlines, has posted U.S. Olympians’ medical and drug testing records online. Although it...more

Samsung Bioepis Biosimilars Update

According to Business Wire, on September 12, 2016, Samsung Bioepis announced that it has added Canada to its growing list of jurisdictions in which it has received regulatory approval for its biosimilar of Amgen’s Enbrel®...more

2016 Mid-Year Global Cartel Enforcement Report

Cartel enforcement activity promises to remain busy In the coming months and into 2017 Cartel enforcement remains a priority for competition authorities around the world. Global cartel fines totaled more than $6...more

EMA Accepts Mylan and Biocon’s MAA for a Herceptin (Trastuzumab) Biosimilar

Last week, Mylan N.V. and Biocon Ltd. announced that the European Medicines Agency has accepted Mylan’s Marketing Authorization Application for a proposed biosimilar version of Genentech’s Herceptin (trastuzumab). Trastuzumab...more

Put the Candle Back: the AstraZeneca FCPA Enforcement Action

I am back from a two-week summer study program at Oxford, run by Michigan State University through its Odyssey to Oxford program. It was a great experience. My class was on The Tudors in film and print so not only did I...more

Lessons Learned from AstraZeneca’s $5.5 Million SEC FCPA Settlement

Last week, the SEC added another pharmaceutical company to its list of FCPA violators when AstraZeneca agreed to a $5.5 million settlement with the SEC. AZ is now the 25th drug or medical device company to pay an FCPA penalty...more

Corporate Investigations and White Collar Defense - August 2016

Spotlight on the False Claims Act - Why it matters: This month, we review a recent Ninth Circuit case that allowed a qui tam relator’s action against various Medicare Advantage organizations to proceed, holding that the...more

Review Published of Nanomaterials for Products and Application in Agriculture, Feed, and Food in the European Union

The European Food Safety Authority (EFSA) requested a review of the already marketed and in-development applications of nanomaterials in the agri/feed/food sectors. The results of the review are published in the August 2016...more

Changes in Cuba May Impact the Insurance Industry

While much remains to be determined, the recent easing of U.S. restrictions on travel to and trade with Cuba may bring opportunities for U.S. and global insurance companies. However, many questions and obstacles remain. This...more

International Experts in Medical Malpractices Cases: Qualification v. Location

The Court of Appeal in Borrayo v. Avery, A143765 (San Francisco County Super. Ct. No. CGC12525769) recently held that a physician licensed to practice medicine in Mexico was qualified to provide an opinion about the standard...more

InSeal Medical Receives CE Mark for Vascular Closure Device

InSeal Medical recently announced that it has received CE Mark approval for its InClosure large bore vascular closure device (VCD). The InSeal VCD provides an internal biodegradable membrane for sealing large cuts in blood...more

Duty Savings Opportunity on Imported Scientific Instruments for Research Institutions

In Depth - US research hospitals and other research institutions that import scientific instruments should take advantage of a US customs procedure that allows foreign instruments to enter duty-free if imported by such...more

Letter to Colombian President Encourages Grant of Compulsory License for Imatinib

Last month, we reported on letters sent by two Senators and fifteen Representatives to the U.S. Trade Representative, seeking clarification regarding the Administration's position on compulsory licenses. The letters were...more

Headlines from Mid-Year FCPA Enforcement Review

Just to add my voice to the cottage industry surrounding FCPA enforcement and compliance, I wanted to take a deep breath and offer some observations on FCPA enforcement in 2016. There are a few significant headlines...more

Hudson Institute Report Refutes UN Panel Stance on Impact of Patents on Access to Medicines

In June, the Hudson Institute released a research report that analyzes several positions taken by the United Nations (UN) High Level Panel on Access to Medicines (HLP) on the impact of patents on global access to medicines. ...more

Workplace Policy Institute Insider Report — August 2016

Littler's Workplace Policy Institute Insider Report details key labor, employment, and benefits news and events at the federal, state, local, and global levels. The August edition of the Insider Report compares the Democratic...more

Your daily dose of financial news - The Brief – 7.22.16

EU financial watchdog ESMA has fined rating agency Fitch Ratings Ltd. $1.5 million for reportedly violating the EU’s rules for rating agencies relating to the 12-hour requirement, internal controls, and unauthorized...more

Corporate Investigations and White Collar Defense - July 2016

“Official Acts”—What They Are… and Are Not - Why it matters: On June 27, 2016, the Supreme Court decided McDonnell v. U.S., holding that, for purposes of the federal public corruption statutes, an “official act”...more

FDA Deep Dive: Real Life Implications of FDA NEST Program Explored

In our Israel Connect Summer 2016 edition we summarized the FDA’s post-market surveillance data programs, including the NEST program designed to consolidate and analyze real-world device data once a device is legally...more

European Life Sciences Review: Issue 3

Welcome to the third issue of our European Life Sciences Review that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

New EU Rules for Medical Devices

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies...more

China Issues Guidance Clarifying Core Tasks and Deadlines for Application of the Country’s Telemedicine System

The Chinese government has been in the process of modernizing its telemedicine law and policy and associated infrastructure for nearly 2 years now, to support broad, domestic application of telemedicine. We outline one of the...more

Three Questions with Former Senate Majority Leader Tom Daschle (D-SD), Founder and CEO of The Daschle Group, a Public Policy...

1. As we head into a new Administration and the new Congress, what do you see as the opportunities and challenges for the Affordable Care Act? The Affordable Care Act (ACA) is much greater than a single legislative action....more

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