The Sunshine Act: Putting It into Practice – Interview with Karen Lovitch, Member, Mintz Levin
Considerations for Biopharma Under a First-Inventor-to-File Regime
Gene Grabowski on Pharmaceutical & Medical Devices
Hot Companies in Digital Health
Digital Health: Where is the Action for Entrepreneurs?
The State Council of China passed amendments to the Regulations on Supervision and Administration of Medical Devices which came into effect on June 1, 2014. The amendments present significant regulatory changes that will...more
China’s State Council released its new Administrative Regulation on the Supervision and Administration of Medical Devices March 7, 2014, which will be effective June 1, 2014 (the “New Regulation”).
The State Council...more
There have been major developments in the trade, solar cells, US/Chinese antitrust, and securities areas.
REASON FOR THIS NEWSLETTER -
Some readers have commented that this newsletter is...more
On March 31, 2014, China Premier Mr.Li Kequiang signed Decree No. 650 on the amended Regulations on Supervision and Management of Medical Devices (“the amended regulations”), which update the original regulations1 released in...more
The Chinese Central Government recently adopted material amendments to the Regulation on the Supervision and Administration of Medical Devices, which will bring significant changes for medical device companies operating in...more
The Regulations on Supervision and Administration of Medical Devices was amended and promulgated by the State Council on March 7th, 2014, effective June 1st, 2014. The last version is from 2000. The following highlights the...more
We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more
On March 31, 2014, China’s State Council released the amended Regulations on the Supervision and Administration of Medical Devices (the “Regulations”), effective as of June 1, 2014. A series of implementing rules are expected...more
On March 13, 2014, the China Food and Drug Administration (the “CFDA”) announced an action plan titled “Rectifications of Five Common Types of Noncompliance Concerning Medical Devices” (the “Five Rectifications Campaign”). A...more
On March 1, 2014, Circular No. 50, which the Chinese National Health and Family Planning Commission (NHFPC) recently promulgated to regulate the conduct of pharmaceutical and medical device companies that do business in...more
China Introduces New Health Care Sector Anti-Corruption Regulations
As part of a concerted effort to tackle systemic commercial bribery in the country’s health care sector, China’s National Health and Family Planning...more
The China Food and Drug Administration recently published a draft regulation setting minimum standards for medical device distribution. The regulation sets forth requirements for procurement, delivery acceptance, storage,...more
On February 7, 2014, the China Food and Drug Administration (“CFDA”) promulgated a notice titled The Fast Track Approval Process for Innovative Medical Device (Tentative), effective as of March 1, 2014. Unlike the draft...more
The China Food and Drug Administration (the “CFDA”) recently published a draft regulation, Good Supply Practices for Medical Devices (the “Draft GSP”), for public comment through January 20, 2014. The first-ever regulation...more
In an article, entitled “GSK China probe flags up wider worries”, in the Wednesday edition of the Financial Times (FT) reporters Andrew Jack and Patti Waldmeir discussed the ongoing bribery and corruption scandal involving...more
Ed. Note-this article is one of a continuing series of interviews of thought leaders in FCPA, Bribery Act and anti-corruption/anti-bribery. In this blog post, I interview Amy Sommers, partner in the Shanghai office of K&L...more
Welcome to the November 2013 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP.
On the anticorruption front, a Swiss tech company’s former exec is charged in the US...more
The China Food and Drug Administration (“CFDA”) recently introduced two important initiatives concerning medical devices.
1) The Tentative Rules on the Review and Approval of Medical Device Clinical Studies (Draft) was...more
In response to the Glaxo controversy and the continuing risks of aggressive FCPA enforcement, drug and device companies need to review and enhance their anti-corruption compliance programs. ...more
What is a sweep? It is certainly a well-known and relevant term in the sporting world....more
As the Glaxo controversy unravels each day, it is important to remember the enforcement context in which the current prosecution in China is occurring. ...more
Mark Twain, one of my favorite authors, always said it best – “Do the right thing. It will gratify some people and astonish the rest.” - For drug and device companies, Mark Twain’s observation is becoming the industry...more
Pharmaceuticals, Medical Devices, Health Care & Life Sciences -
.. Medical Devices
Regulations and News -
Provincial FDAs to Approve Certain Changes to Medical Device Registration Certificates – June 21,...more
This week, reports have arisen that Chinese authorities in the cities of Shanghai, Beijing, and Changsha detained high-level GlaxoSmithKline (GSK) managers as part of an investigation into potential “economic crimes.” The...more
In March 2013, the National People’s Congress of China formally changed the name of the State Food and Drug Administration (SFDA) to the China Food and Drug Administration (CFDA), elevating it back to a ministerial-level...more
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