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The New EU Clinical Trials Regulation Aims at Harmonization and Transparency

On June 16, 2014, Reg. (EU) No. 536/2014 on Clinical Trials on Medicinal Products for Human Use (Regulation) has entered into force. Once it becomes applicable, the Regulation will provide a comprehensive legal framework for...more

Africa Update - October 2014 #3

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

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

One important reason why healthcare whistleblowers need to be protected

Because they have first sight into the safety and treatment of patients - There's been much in the media spotlight lately around UK healthcare whistleblowers. The scandal-hit Stafford Hospital has had it's fair share...more

Legislative Update Report No. 2014-19

In This Article: - Federal Government - Alberta - British Columbia - Manitoba - New Brunswick - Newfoundland - Northwest Territories - Nova Scotia - Nunavut - Ontario - Prince Edward...more

China Widens Entry to Medical Device Market to Investment, Innovation While Tightening Regulations on Existing Market Products

As the medical device industry in China continues accelerated growth, investors seek to capitalize on a roughly $65 billion market that is growing at an annual rate of 21 percent. Under recent changes to the regulatory...more

Africa Update - October 2014 #2

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

FDA Announces More Changes to FSMA Implementation Rules

On September 19, 2014, FDA announced potential changes to four rules that the agency proposed in 2013 to implement the Food Safety and Modernization Act (“FSMA”). FSMA was signed into law in January 2011 in response to many...more

Africa Update - October 2014

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

China Update - September 2014 #2

In This Issue: - Doing Business in China - U.S-China Relations - Energy & Environmental - Food Safety - Health Care - Trade - Excerpt from Doing Business in China: The...more

Realizing the Potential of Telemedicine in China, Part 1: Protecting Your IP

This post is the second in Foley’s blogs on China telemedicine and the first in the blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the...more

China Amps Up Anti-Corruption Effort – What This Means for Your Company

Last Friday, China’s 15-month-long bribery investigation into British multinational pharmaceutical GlaksoSmithKline (GSK) ended after a one-day trial in which the court found GSK’s local subsidiary guilty of bribing doctors...more

Africa Update - September 2014 #4

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

Lame Duck Preview

With the November elections looming, the House and Senate completed their work last week before departing Washington to campaign, leaving any remaining legislative work for the post-election lame duck session. The brief work...more

Privacy Tuesday – September 2014

Happy autumnal equinox Home Depot Breach – By the Numbers: - 56 million cards at risk (compare to Target = 40 million) - $62 million in estimated costs (compare to Target =$146 million and...more

Health Alert (Australia) - September 22, 2014

In This Alert: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales - 17 September 2014 - Southern Radiology Nuclear Medicine v Environmental Protection Authority (EPA)...more

Africa Update - September 2014 #3

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

China Issues New Telemedicine Opinions for China and Foreign-Based Providers

Telemedicine providers and vendors doing business in China, whether based in China, the United States, or elsewhere, received new guidance on the use of telemedicine in China....more

FDA Regulatory and Compliance Monthly Recap

Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through the...more

China’s NHFPC issues Opinions on Promotion and Administration of Telemedicine Services

In recent years, China’s central government has made substantial investments to support the development of telemedicine. According to statistics from the National Health and Family Planning Commission (NHFPC), there were...more

Health Alert (Australia) - September 15, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgements: New South Wales (NSW)- 9 September 2014 - Appleton v Norris [2014] NSWCA 311 - In August 2013, Ms Appleton...more

Medical Device Manufacturer Settles Trade Agreements Act Suit

A whistleblower alleged that the manufacturer knowingly violated the Trade Agreements Act’s country of origin requirement. Government contractors must agree that the products they sell to the U.S. government under...more

China Allows Wholly Foreign-Owned Hospitals in Seven Pilot Cities and Provinces

On 28 August 2014, the Ministry of Commerce (MOFCOM) and the National Health and Family Planning Commission (HFPC) jointly released the Notice of the National Health and Family Planning Commission and the Ministry of Commerce...more

Health Alert (Australia) - September 1, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Victoria - 27 August 2014 - Finding of Inquest into the Death of Robert Vivian Hawkins COR 2010/0520 - In...more

Africa Update - August 2014 #4

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

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