Commercial Law & Contracts, International Law & Trade, Health Law

China Life Sciences Health Industry Client Briefing – April 2013 (May 15, 2013)

by Vicki Lung, Gordon B. Schatz, Katherine Yang, Amy Yin | Reed Smith on 5/15/2013

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Drugs - Approval of Innovative Drugs and Key Sector Generic Drugs to be Expedited (Shanghai Securities Journal 2013-04-23): Given the...more

Focus on Health Care Firms in FCPA Investigations

by Doreen Edelman | Baker, Donelson, Bearman, Caldwell &... on 4/10/2013

I am seeing a lot of interest from health care clients regarding the Foreign Corrupt Practices Act (FCPA). I usually stay away from this topic because so many others cover it in detail. However, I want to point out that in...more

CMS Publishes Final Sunshine Act Rule; Data Collection to Begin on August 1, 2013

by Brian P. Dunphy, Kimberly J. Gold, Karen S. Lovitch, Kate Stewart | Mintz Levin - Health Law on 2/5/2013

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more

Chinese FDA Imposes Mandatory Electronic Barcoding on Imported Drugs

by Katherine Wang | Ropes & Gray LLP on 2/5/2013

The State Food and Drug Administration (“SFDA”) issued a Notice on Relevant Issues Concerning Imposing Electronic Barcoding on Imported Drugs (“Notice”) on January 29, 2013 with immediate effect. Pursuant to the Notice,...more

Pfizer FCPA Settlement Emphasizes the Importance of Robust Compliance Programs for the Healthcare Industry

by Bora Rawcliffe | Sheppard Mullin Richter & Hampton LLP on 1/23/2013

The healthcare industry has been under increased SEC and DOJ scrutiny lately for potential FCPA violations. What has been described as an “industry sweep,” has focused primarily on medical device and pharmaceutical companies....more

Infobytes - A Weekly In-depth review of news & developments in the financial services industry - January 18, 2013

by BuckleySandler LLP on 1/22/2013

In This Issue: - FEDERAL ISSUES - STATE ISSUES - COURTS - FIRM NEWS - FIRM PUBLICATIONS - MORTGAGES - BANKING - CONSUMER FINANCE - E-COMMERCE - PRIVACY/DATA SECURITY - PAYMENTS -...more

China Life Sciences and Health Industry Client Briefing – November 2012 (December 13, 2012)

by Mao Rong, Gordon B. Schatz, Hugh T. Scogin , Jr., John Tan, May Ling Wong, Jay J. Yan, Katherine Yang, Amy Yin | Reed Smith on 12/17/2012

In This Issue: Priorities, Practical Tips and Lessons Learned from Reed Smith’s China Device Regulatory Briefing on December 4, 2012; Programs of Designated Drug Production to be Initiated: Five to 10 Pilot Varieties...more

DOJ and SEC Issue Highly Anticipated FCPA Guidance

by Mintz Levin - Health Law on 11/16/2012

On November 14th, the U.S. Department of Justice (“DOJ”) and the U.S. Securities and Exchange Commission (“SEC”) published A Resource Guide to the U.S. Foreign Corrupt Practices Act, their long-awaited, highly anticipated...more

Inside M&A - Fall 2012

by Paul J. Kim, Nicolas Lafont, Obiamaka P. Madubuko, Jeffrey Rothschild, Jake Townsend | McDermott Will & Emery on 11/15/2012

In This Issue: Bridging the Cross-Border M&A Gap “Korean Style”; Corporate Buyers Beware: FCPA Successor Liability – A Growing Threat; Investing In the Chinese Health Care Sector: A New Frontier to be Explored with Care;...more

Chinese FDA Soliciting Public Comments on Rules for Re-Packaging of IVDs

by Katherine Wang | Ropes & Gray LLP on 11/15/2012

The State Food and Drug Administration (“SFDA”) in China published a draft of the Tentative Measures for the Administration of the Registration of Re-Packaging In-Vitro Devices (IVDs) (“Draft Measures”) on November 2 for...more

OFAC Publishes New Iranian Transactions and Sanctions Regulations

by McDermott Will & Emery on 10/24/2012

Recently the U.S. Treasury Department Office of Foreign Assets Control (OFAC) issued new Iranian Transactions and Sanctions Regulations. Notably, the regulations formally address financing provisions for authorized sales to...more

Clearance: Proskauer's Quarterly Antitrust Update - Fall 2012

by Proskauer Rose LLP on 10/12/2012

In This Issue: - Exchange Of Employee Wage Information: What Is Permitted Under The Antitrust Laws? - Minn-Chem Maximizes Sherman Act's Reach - The FTC Goes Retro to Win Down South - 7th Circuit Clarifies...more

French Sunshine Act: Implementing Decree to Be Published No Later than October 2012

by McDermott Will & Emery on 9/7/2012

French Law No 2011-2012 on the Strengthening of Health Protection for Medicinal and Health Products, dated 29 December 2011 (known as the French Sunshine Act), imposes new disclosure obligations to health products companies. ...more

The European Court affirms that public safety comes first: financial considerations cannot justify the placing on the market of...

by White & Case LLP on 7/17/2012

Abstract: On 29 March 2012, the European Court of Justice (CJEU) issued a ruling in a case brought by the European Commission against Poland declaring unlawful the supply of unlicensed medicines on financial grounds as a...more

Challenges in Ensuring Anti-Corruption Compliance by Distributors

by Michael Volkov on 7/5/2012

The Justice Department’s recent enforcement action against Smith & Nephew underscored an important point – companies can be responsible for FCPA violations committed by distributors of the company’s products. FCPA compliance...more

“Sunshine” on Physician Payments

by Michael Volkov on 6/5/2012

It is amusing to listen to companies complain about the burdens of anti-corruption compliance. It is hard to sympathize when you consider the burdens on other industries, particularly the health care industry. If the...more

2012 March Edition of China Senior Housing and Care Newsletter

by Qin Qu on 5/20/2012

Following are the contents of this edition: News Update Two Different Types of Senior Community Emerge Respectively in Shanghai and Beijing Senior Nursing –- a Rising and Promising Career Indemnificatory Housing is...more

Baker & McKenzie: Pharmaceuticals & Healthcare Asia Pacific Newsletter - 1st Quarter 2012

by Baker & McKenzie Australia on 5/16/2012

Four Rules for Interacting with Healthcare Professionals in the Asia Pacific Facing legal sanctions and cultural gaffes is a reality when dealing with healthcare professionals in the Asia Pacific. In this...more

DOJ Reaches FCPA Settlement With Medical Device Company

by BuckleySandler LLP on 4/2/2012

On March 26, the U.S. Department of Justice (DOJ) announced it had reached a settlement with a medical device company to resolve allegations that the company and its subsidiaries made improper payments in violation of the...more

An Introduction on China’s Senior Pension Mechanism

by Qin Qu on 4/1/2012

While China’s aging population rapidly grows in recent years, combining with raising expanse for living, more and more people are concerning about their retirement fund—how they can support themselves on medical expenses and...more

In The Rush To Emerging Markets, Could Public Health Be The Winner?

by Sheppard Mullin Richter & Hampton LLP on 3/20/2012

Originally Published in The Metropolitan Corporate Counsel, March 2012. What is the crashing noise so many pharmaceutical companies are hearing these days? Some say it is the sound of key products going over the “patent...more

IFPMA Releases Revised Code for Interactions with Health Care Professionals and Other Stakeholders

by McDermott Will & Emery on 3/16/2012

On March 1, 2012, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) issued a Code of Practice relating to interactions with the health care community, which replaces and expands upon its 2006...more

Guidelines for Medical Devices in the UAE Healthcare Industry

by Michael Diaz Jr. - Diaz Reus International... on 3/9/2012

Healthcare is among the priority sectors identified by the UAE government and as a result, the UAE healthcare industry has displayed extraordinary growth and significant progress in the past few years. In line with the UAE...more

China Briefing - December 2011

by Reed Smith on 1/17/2012

Pharmaceuticals, Devices, Health Care & Life Sciences Regulatory and Policy Changes • Catalogue of Class II Medical Devices Exempted from Submitting Clinical Trial Materials (for Trial Implementation) Issued (State...more

European Court Moves to Protect Online Selling

by Reed Smith on 10/21/2011

Following are links to the decision of the European Court in the Pierre Fabre case (referral from the French Court of Appeal) (English version, French version), which concerned an absolute ban on selling products other than...more

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Commercial Law & Contracts › International Law & Trade › Health Law