International Trade Science, Computers & Technology Health

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FDA Releases Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

On April 21, 2015, the Food and Drug Administration (FDA) issued a notice announcing the availability of a draft guidance document clarifying the Agency’s acceptance of medical device clinical data from studies conducted...more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

The U.S. Complaint Against the Government of China in the WTO, Including the Targeting of Chinese Medical Device Manufacturers

On February 11, 2015, the United States filed a complaint before the World Trade Organization (WTO), alleging that certain actions by the national, regional and local governments of the People’s Republic of China are in...more

European Clinical Trial Regulations Public Consultation – Confidentiality Concerns

Clinical Trial Regulations - On 21 January 2015, the European Medicines Agency (EMA) began a public consultation on the new European Clinical Trial Regulations (CTRs)....more

Health Alert (Australia) - February 9, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Western Australia (WA) - 29 January 2015 - Yoong And Medical Board Of Australia [2015] WASAT 6 - National Law -...more

FDA Requests Comments on WHO Recommendation to Classify Two Common Industrial Solvents as Psychotropic Substances

On January 27, 2015, the Food and Drug Administration (“FDA”) requested comments on a recommendation by the World Health Organization (“WHO”) to classify two common industrial solvents – gamma-butyrolactone (“GBL”) and...more

Health Alert (Australia) - February 2,2015

In This Issue: Judgments; Legislation; and Reports & Publications. - Excerpt from Judgments: New South Wales (NSW) - Janet Harris v Sydney Local Health District [2014] NSWDC 21 - The...more

Health Alert (Australia) - January 27, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Reports: Ensuring National Capacity in Genomics-Guided Public Health Laboratory Surveillance. Australia. Department of Social...more

Privacy Tuesday - January 2015

Good Tuesday – The East Coast prepares for Apocalypse (Sn)ow. In the meantime, here are three privacy-related tidbits for your day. Privacy Concerns Cause Scale Back of Release of HealthCare.gov Data - We...more

Ensuring Data Protection In The Implementation Of The EFPIA Disclosure Code: Key Challenges And How Pharmaceutical Companies Are...

The EFPIA Disclosure Code will, from 2016, require pharmaceutical companies to disclose details of payments and transfers of value made to healthcare professionals and healthcare organisations. The Code aims to promote,...more

Healthcare & Life Sciences Private Equity Deal Tracker: CardioDx Secures $35 Million in Financing

CardioDx, headquartered in Redwood City, Calif., is a molecular diagnostics company specializing in cardiovascular genomics. Participants in this round of financing included Alberta Investment Management Corp. and the...more

Health Alert (Australia) - December 22, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales - 19 December 2014 – Dr Reid v Medical Council of NSW - [2014] NSWCATOD 152 - The Medical Council...more

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