Health International Trade

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
News & Analysis as of

[Webinar] Mid-Sized Companies and Anti-Corruption: How to manage corruption risks with limited resources - May 28, 11:00 am EST

Instances of corruption can have a significant impact on a company’s finances and reputation. With international anti-bribery enforcement actions on the rise, it is essential for companies to implement an anti-corruption risk...more

Health Alert (Australia) - May 18, 2015

In This Issue: Judgements; Legislation; and Reports. - Excerpt from Judgments: Queensland - 8 May 2015 - Vega Vega v Hoyle [2015] QSC 111 - The Queensland Supreme Court has held that...more

Why the Health Care Industry Needs to Focus on Data-Flow Restrictions in China

U.S. health care providers, device manufacturers, lab managers, health information technology and telemedicine/telehealth project investors, and other industry members involved in projects in China, need to be aware of a long...more

Health Alert (Australia) - May 11, 2015

In This Issue: Judgments, Legislation; and Reports and Publications. Excerpt from Legislation: Commonwealth - 5 May 2015 - Australia New Zealand Food Standards Code — Standard 1.4.2 — Maximum Residue...more

Life Sciences Spotlight - Asia Pacific - Issue 5, 2015

In This Issue: - Harper Review Dispenses Important Recommendations For The Life Sciences Sector - Pharmaceutical Patent Term Extensions In Australia - PRC Anti-Corruption Regime 101 - Revisions To The Medicines...more

April Whistleblower News Digest | Consider Targeted Anti-Retaliation Training as part of Your Ethics and Compliance Training...

If April showers bring May flowers, then May is going to be a veritable hurricane of whistleblower-related fines (and also pollen). Our first three items come to us from the SEC, with awards and fines galore, most notably the...more

Recently Finalized FDA Guidance Indicates Some Flexibility for Biosimilars

Earlier this month the Food and Drug Administration ("FDA") published three industry guidances for the Biologics Price Competition and Innovation Act of 2009 ("BPCIA")....more

OIG Report: FDA Has Made Progress on Oversight/Inspections of Manufacturers of Generic Drugs

Yesterday the OIG posted a report entitled “FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs” in response to a Congressional request expressing concerns about the safety and quality of...more

Health Alert (Australia) - May 4, 2015

In This Issue: Judgments; Legislation; and Reports & Publications. Excerpt from Reports & Publications: Queensland. Office of the Health Ombudsman 24 April 2015 - Health Ombudsman releases third...more

Africa Update - April 2015 #4

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub - Saharan Africa - General Africa News -...more

Can My U.S. Company Offer Online Second Opinions in China?

This post is the sixth in Foley’s blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the Chinese telemedicine market. As U.S. companies continue...more

FDA Issues Draft Guidance Addressing Reliance on Ex-U.S. Clinical Data in Medical Device Premarket Submissions

On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more

FDA Issues Draft Guidance Document on Acceptance of Foreign Medical Device Clinical Data

The FDA recently issued a draft guidance document regarding its policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices. In view of the...more

Health Alert (Australia) - April 28, 2015

In This Issue: Judgments; Reports; and Legislation. Excerpt from Judgments: Australia. Federal Court - 15 April 2015 - Australian Competition and Consumer Commission v ACN 117 372 915 Pty Limited (in...more

FDA Releases Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

On April 21, 2015, the Food and Drug Administration (FDA) issued a notice announcing the availability of a draft guidance document clarifying the Agency’s acceptance of medical device clinical data from studies conducted...more

Africa Update - April 2015 #3

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub - Saharan Africa - General Africa News - Excerpt...more

Health Alert (Australia) - April 20, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales (NSW) - 13 April 2015 - Sarah White v The Local Health Authority & Anor - [2015] NSWC 417 - The New South...more

Trade Agreements Act Compliance Activity Increasing at VA

Companies should include internal TAA compliance reviews in their overall manufacturing compliance programs. Every manufacturer of medical devices and pharmaceuticals that offers a product for sale to the federal...more

Update on Significant DOT, FAA and Other Federal Agencies’ Aviation-Related Regulatory Actions - April 2015

This edition of the Cozen O’Connor Aviation Regulatory Update includes an overview of the FAA’s new contract maintenance rules, DOT and FAA notices on flight prohibitions in conflict zones, the latest news on the integration...more

Africa Update - April 2015 #2

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub - Saharan Africa - General Africa News - Excerpt...more

Generic Drug Manufacturers to be Investigated by HHS for Recent Price Hikes

On April 13, 2015, the Inspector General (IG) of the Department of Health and Human Services announced in a letter to Senator Bernard Sanders (I. VT), that it would investigate recent price hikes for generic drugs. Generic...more

Blog: The Trade Agreements Act and Sales of Medical Devices to the U.S. Government

Does your company sell medical devices to the U.S. Government, either directly or through a reseller or distributor? Are those devices or supplies manufactured at least partly in a country other than the U.S.? ...more

Africa Update - April 2015

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub - Saharan Africa - General Africa News - Excerpt...more

SCENIHR Identifies Use of Nanomaterials for Medical Imaging and Drug Delivery and Graphene Nanomaterials as Emerging Issues

On April 9, 2015, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a Position Statement on emerging and newly identified health risks to be drawn to the...more

DOJ Announces Indictment of U.S. Senator Menendez and Friend Salomon Melgen for Conspiracy, Bribery, and Honest Services Fraud

On April 1, the DOJ indicted Senator Robert Menendez and Florida ophthalmologist Salomon Melgen for an alleged bribery scheme in which Menendez accepted financial gifts from Melgen in exchange for using his position of power...more

378 Results
|
View per page
Page: of 16

Follow Health Updates on:

All the intelligence you need, in one easy email:

Great! Your first step to building an email digest of JD Supra authors and topics. Log in with LinkedIn so we can start sending your digest...

Sign up for your custom alerts now, using LinkedIn ›

* 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.
×