International Trade Health Science, Computers & Technology

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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

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

FDA Issues Draft Guidance Addressing Reliance on Ex-U.S. Clinical Data in Medical Device Premarket Submissions

On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more

FDA Issues Draft Guidance Document on Acceptance of Foreign Medical Device Clinical Data

The FDA recently issued a draft guidance document regarding its policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical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

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

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

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

FDA Approves Expanded Use of Medtronic’s CoreValve System; Also Receives Regulatory Approval in Japan

Last week the U.S. Food and Drug Administration announced its approval of Medtronic’s CoreValve system for “valve-in-valve” (VIV) replacement. According to the FDA press release, this represents the first transcatheter aortic...more

European Generics and Biosimilars – Legal Trends and More Discussed at 11th Annual Legal Affairs Forum – Part One of Two

On March 26-27, 2015, the European Generic and Biosimilar Medicines Association (“EGA”) held its 11th Annual Legal Affairs Forum. The Forum kicked off with an introduction by Sergio Napolitano, Legal Affairs and Trade...more

Health Alert (Australia) - March 30, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales - 25 March 2015 - Smythe v Burgman (No 2) [2015] NSWSC 150 - The New South Wales Supreme Court has held...more

Health Alert (Australia) - March 23, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Reports: New South Wales (NSW). Ministry of Health - Media Releases - 18 March 2015 - NSW says protect against mosquitoes after huge...more

Medical Device Companies Face Severe FCA Penalties for TAA Violations

A spate of recent multi-million dollar settlements has shown that medical device manufacturers are subject to substantial liability under the False Claims Act (FCA) if they misstate the country of origin of their products in...more

Health Alert (Australia) - March 16, 2015

In This Issue: Judgments; Legislation; and Publications & Reports. Excerpt from Publications & Reports: American Medical Association (AMA) - 12 March 2015 - New AMA, CDC Initiative Aims to 'Prevent...more

China Telemedicine Tackles Long Term Care: Business Opportunities and Government Guidance

This post is the fifth 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. A China government policy...more

Health Alert (Australia) - March 9, 2015

In This Issue: Judgments; Legislation; and Reports. - Excerpt from Judgments: Australia. Federal Court - 5 March 2015 - Australian Nursing and Midwifery Federation v Kaizen Hospitals (Essendon) Pty Ltd...more

Do You Really Know Your China Telemedicine Partners? China Anti-Corruption Effort Focuses on Major Medical Institutions

This post is the fourth 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....more

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