Ask a CFIUS Expert: Is Crypto Spying on Us?
Hot Topics in International Trade-Braumiller Law Group-FDI Into Mexico from China
4 Key Takeaways | Solar Industry & Chinese Tariff Update
10 Key Trade Developments: Trade Remedy Cases
Episode 309 -- Alex Cotoia on Compliance with the Uyghur Forced Labor Prevention Act
10 Key Trade Developments: China
Noteworthy Points in the Rules for the Implementation of China's Patent Law 2023
JONES DAY TALKS®: Corporate Compliance in Asia: Managing Rapid Regulatory Change and Ambiguity
Hot Topics in International Trade. Braumiller Law Group Partner & Founder Adrienne Braumiller joins Vp of Marketing Bob Brewer for an Update on Forced Labor
Episode 292 -- 3M's $6.5 Million FCPA Settlement with the SEC
5 Key Takeaways | How to Effectively Leverage the Chinese Patent System
Third Party Observation in Patent Prosecution in China
The Grace Period for Novelty in Chinese Patent Law
One Month to a More Effective Compliance Program with Boards – Day 14 - Boards and Doing Business in China
Episode 276 -- Review of Phillips and Franks Int'l SEC FCPA Settlements
Sanction and the Increasing Complexity of Trade Compliance
Braumiller Law Group Help With China Imports
Coming Conflict with China: Part 5 - Good Compliance Is Good Business
JONES DAY PRESENTS®: Taiwan's Enhanced Trade Secret Restrictions and Stricter Penalties
JONES DAY PRESENTS: The Challenges of Defending Trade Secrets in China
This article provides a general overview of certain Chinese legal considerations for licensing and collaboration deals in the life sciences industry. In particular, this article focuses on two types of transactions...more
The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology, drug, and medical device companies to do business with...more
In recent years, there has been an uptick in interest in the Chinese market from licensors based predominantly in the U.S., Canada, Europe, and South Korea. Factors encouraging the in-licensing of products to China include...more
ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more
The Ministry of Science and Technology of China has finally issued the draft of Implementation Rules for the Regulations of Human Genetic Resources Administration for public comments on March 21, 2022, which gives more...more
On 18 March 2021, the State Council of China announced certain amendments (the 2021 Amendment) to the Regulation on the Supervision and Administration of Medical Devices (the Medical Device Regulation). The 2021 Amendment...more
China recently amended its primary regulation governing medical devices, the Regulation on Supervision and Administration of Medical Devices (2021 RSAMD), which will replace its previous 2014 version and become effective on...more
In 2020, heightened demand for health care resulted in an influx of therapeutic goods being included on the Australian Register of Therapeutic Goods (ARTG). A large portion of these goods are manufactured in China however,...more
Yesterday, the US Food and Drug Administration (FDA) revised its Emergency Use Authorization relating to disposable respirators made in China that are not approved by the US National Institute for Occupational Safety and...more
China is cautiously recovering from the peak of the COVID-19 outbreak and is moving into a new period of investor-friendly policies aimed at restarting China’s economic engine....more
As the coronavirus (COVID-19) spreads across the world, creating new epicenters, this is perhaps an opportune moment to look back at the lessons learned from China, where it appears that the outbreak is under control, in...more
On 16 March 2020, the European Commission published Recommendation (EU) 2020/403 of 13 March on conformity assessment and market surveillance procedures within the context of the COVID-19 threat. The objective of the...more
In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more
The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more
U.S. and international health authorities continue to respond to the outbreak of the novel coronavirus (COVID-19). While originally detected in Wuhan City, Hubei Province, China, as of the date of this alert the virus has now...more
How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the classification of devices, and...more
In a week that’s already seen plenty of C-suite shakeups, we’ve learned that Ginni Rometty is stepping down from her role as CEO at IBM. The company’s cloud computing chief, Arvind Krishna, will take over for her, though...more
The annual gathering of life sciences executives and investors in San Francisco that many now call “JPM Week” recently concluded, marking the J.P. Morgan Healthcare Conference’s 38th year....more
EU – REGULATORY - Brexit, Notified Bodies, and Medical Devices - The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more
I continue with the multi-part blog post series based upon the New York Times (NYT) article by Alexandra Stevenson and Sui-Lee Wee, entitled “Selling CT Scanners with Bricks of Bills in China”, which details allegations of...more
After a sidetrack into the ethical train wreck detailed by the SEC Cease and Desist Order re: KPMG yesterday, I am returning to the blog post series I am running based upon the New York Times (NYT) reporting by Alexandra...more
Data Inspections in China: Increased Supervision and Compliance - Data protection inspections have become more frequent for companies with operations in China. Many companies are struggling for guidance on how to comply. ...more
China’s State Administration for Market Regulation (SAMR) has announced the launch of a nationwide campaign to crack down on unfair competition and commercial bribery in the pharmaceutical, medical device and educational...more
On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for eight international medical device manufacturers located in U.S., Europe, Japan, and Australia under its Medical Device Good...more
BioArctic AB, a public Swedish biopharma company, recently announced that they received allowance of a patent application directed to a method of promoting axonal regeneration using a biodegradable spinal cord device. The...more