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JAMS Dispute Resolution Alert, Summer 2014

In This Issue: - Experts Predict ADR Will Help Resolve Affordable Care Act Claims - ADR News & Case Updates - Domestic Focus ..Supreme Court Ruling Expands Whistleblower Protections - Good...more

China Amends Key Medical Device Regulations

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

Legal and Ethical Risks of Healthcare Businesses in China

Recent disputes and controversies involving Chinese subsidiaries of foreign pharmaceutical companies have sounded warning bells on legal and ethical issues regarding participation in China’s rapidly growing and evolving...more

Changes of the Amended Regulations on Supervision and Administration of Medical Devices

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

Overview of Primary Provisions of U.S. and French Sunshine Reporting Requirements

2013 was a year of unprecedented scrutiny of financial relationships between manufacturers and health care professionals, such as physicians. Both the United States and France imposed sweeping new reporting and disclosure...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - 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

China Cracking Down On Pharmaceutical Corruption

Stricter Blacklist Regime - On December 25, 2013, the National Health and Family Planning Commission of China (“National Health Commission”, former Ministry of Health) issued the amended Provisions Regarding the...more

Privacy and Security Becoming More Increasingly Critical

Privacy and security continue to be critical considerations for all businesses. While such considerations in the healthcare industry have received a lot of attention over the past years with the increasing requirements under...more

China Compliance Update: Commercial Bribery Risks Remain Very Real in China

The enactment of new legislation, as well as new and continuing investigations, demonstrates that Chinese regulators have not slowed down their efforts to ferret out corruption in the pharmaceutical sector and related...more

Healthcare Enforcement Actions and Trends: 2013 Overview

The Department of Justice (DOJ) and the Office of Inspector General for the U.S. Department of Health and Human Services continued aggressive enforcement of the healthcare industry in 2013. Officials employed a variety of...more

FTC Workshop Seeks to Spark Biosimilars Competition

Demand for biologics is growing fast, but even after Congress passed authorizing legislation in 2010, the pace of generic entry appears to have stalled. Seeking to spur increased generic competition, the FTC held an all-day...more

China Solicits Comments on Good Supply Practices for Medical Devices

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

Judge Finds Illinois Insurance Department's Policy Prohibiting Offshoring To Be Improper Rulemaking

On November 27, 2013, the Circuit Court of Cook County, Illinois issued an Order in a lawsuit filed by the American Council of Life Insurers, Inc. ("ACLI") v Andrew Boron, Director of the Illinois Department of Insurance and...more

Planes, trains and Over-the-Counter pills

This Reed Smith client alert looks at the recent amendments to the Human Medicines Regulations 2012, which came into force in November 2013....more

China Expects Major Changes in Drug Registration and Contract Manufacturing Rules

The China Food and Drug Administration (“CFDA”) recently announced several draft rules, most notably, the Draft Amendment of the Provisions for Drug Registration (also known as the Drug Registration Rules, DRR) and the Draft...more

SEC Administrative Action Resolves Foreign Bribery Allegations

On October 24, the SEC released a cease-and-desist order that resolves FCPA allegations against a Michigan-based medical technology company. The SEC alleged that the company’s subsidiaries in five different...more

China Solicits Comments on Post-Market Study Guidelines

The Center for Drug Evaluation (“CDE”) in China recently published the draft Guidelines for the Administration of Post-Market Studies on Chemical Drugs and Therapeutic Biologics (“Draft Guidelines”) for public comments...more

Tax Talk -- Volume 6, No. 3 -- October 2013

In This Issue: A Primer on the Medical Device Excise Tax; FATCA Registration Begins; In re Downey Financial Corp. (U.S. Bankr. Court Dist. of Delaware 10/8/2013); In re NetBank (11th Cir. 9/10/2013); and In re...more

China Enhances Regulatory Oversight of Medical Device Studies and Vigilance

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

The Cost Of Stupid Is Less Than The Cost Of Bribery And Corruption

After the butt-slide play, you might think that the sad sack Houston Astros could not sink even lower but I guess setting the Major League Baseball (MLB) record for the worst record for three straight years is not enough....more

China’s Life Sciences Regulatory Crackdown: September 10 Update

The regulatory enforcement environment in China remains tense, as both the Chinese government and media bring new actions and allegations against life sciences manufacturers in both the pharmaceutical and device sectors. We...more

GSK And Missed Red Flags In China

One of the questions that GlaxoSmithKline PLC (GSK) will have to face during the next few years of bribery and corruption investigations is how an allegedly massive bribery and corruption scheme occur in its Chinese...more

Lessons Learned from the GlaxoSmithKline Bribery Investigation

The recent enforcement of Chinese anti-bribery laws against British pharmaceutical company GlaxoSmithKline (GSK) highlights the compliance challenges faced by foreign companies operating in China....more

Chinese Probe Into GSK—Media Reports and Legal Analysis

An unknown number of employees of GlaxoSmithKline (China) Investment Co. Ltd., the local subsidiary of the British multinational corporation GlaxoSmithKline plc. (GSK), were detained on allegations of data fraud and bribery...more

Chinese Investigation of GlaxoSmithKlein Broadens as Details Emerge

In the weeks since our first post on the Chinese investigation of GlaxoSmithKlein (GSK) for alleged “widespread bribery of doctors” to induce the prescription of GSK’s drugs, more details have emerged about the bribery...more

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