Health Law, International Law & Trade

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

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

by John T. Bentivoglio, Jennifer L. Bragg, Maya Florence, Michael K. Loucks, Gregory M. Luce | Skadden, Arps, Slate, Meagher & Flom LLP on 5/15/2013

Executive Summary - On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more

How to Minimize FCPA Risk in Health Care Acquisitions

by Mintz Levin - Health Law on 5/10/2013

When acquiring a health care company doing business abroad, there is no such thing as being too thorough with anti-corruption due diligence. The Department of Justice and the Securities and Exchange Commission have the...more

Favorable Temporary ACA Exemption for Expatriate Health Plans

by Amy Gordon, Megan Mardy, Todd Solomon | McDermott Will & Emery on 5/2/2013

Recently issued guidance addresses the unique compliance issues surrounding expatriate health plans under the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act...more

Cross-Border Crashes: How Canadian Healthcare Can Affect Your Settlement

by Law Office of Dean Standish Perkins and... on 4/30/2013

Despite the efforts to prevent accidents, crashes with Canadian drivers are still an all too common occurrence in Washington State. To make matters worse, dealing with Canadian insurance companies can be confusing and...more

US Sues Novartis for Alleged Pharmacy Kickback Scheme

by Josh Crank | Lawyers.com on 4/30/2013

Swiss drug maker Novartis has been sued by a U.S. Attorney for allegedly paying kickbacks to pharmacies that converted thousands of patients to one of its drugs. The civil fraud suit accuses the company of disguising the...more

China Life Sciences Health Industry Client Briefing – March 2013 (April 26, 2013)

by Vicki Lung, Gordon B. Schatz, Katherine Yang, Amy Yin | Reed Smith on 4/29/2013

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Medical Devices - CFDA Seeks Public Comment on Special Approval Procedures for Innovative Medical Devices: China Food and Drug...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

Health Care Reform Update -- April 2, 2013

by Joseph P. Hammang, Alexander Hecht, Kevin M. Kappel, Tom Koutsoumpas, Jeremy Rabinovitz, Robert C. Skinner | Mintz Levin - Health Law on 4/3/2013

In This Issue: Implementation of the Affordable Care Act (ACA); Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups...more

Fully-Insured Expatriate Health Plans Get Extra Time to Comply with PPACA

by Tzvia Feiertag | Proskauer - ERISA Practice Center on 3/21/2013

Recognizing that expatriate group health plans may find it impossible, or nearly impossible, to comply with all of the relevant provisions of the Patient Protection and Affordable Care Act of 2010 (PPACA), the U.S. Labor...more

China Clarifies Fast Track Approval Eligibility for Novel Biologics

by Katherine Wang | Ropes & Gray LLP on 3/13/2013

The Chinese State Food and Drug Administration (“SFDA”) created a fast track review and approval process for novel drugs in its Drug Registration Rules issued in 2007. The fast track approval process is available for (1)...more

Capital Thinking Update - March 11, 2013

by Amy Davenport, Tanya DeRivi, Eugenia Edwards, Jared Fleisher, Mara Giorgio, Jessica Monahan, Amy Budner Smith, Stacy Swanson, Joseph Urso, Sarah Vilms, Dana Weeks, Pam Welsh | Patton Boggs LLP on 3/13/2013

In This Issue: - General Legislative - Agriculture and Food - Budget, Appropriations and Sequestration - Cybersecurity - Defense - Education - Energy - Environment - Financial Services -...more

China Life Sciences Health Industry Client Briefing – February 2013 (March 11, 2013)

by Vicki Lung, Mao Rong, Gordon B. Schatz, John Tan, May Ling Wong, Jay J. Yan, Katherine Yang, Amy Yin | Reed Smith on 3/12/2013

In This Issue: New Drug GSP Issued: Supervision on Drug Distribution to be Enhanced (China Securities Journal 2013-02-20) – February 20, 2013; China to Encourage Innovative Drug Development (Xinhua News Agency...more

News from Abroad: Bill to Diminish Term of Patents for Medicaments

by McDonnell Boehnen Hulbert & Berghoff LLP on 3/6/2013

Originally published in Olivares & Cia. on March 4, 2013. In January, the Mexican Senate published a Bill adding article 23 bis to the Industrial Property Law (IP Law). This Bill intends to establish a "special" life...more

New People's Republic of China (PRC) Regulations for Centralized Procurement of Medical Consumables Contain Significant Penalties...

by Christine Liu, Gordon B. Schatz, John Tan | Reed Smith on 2/22/2013

On December 17 2012, China’s Ministry of Health, in conjunction with five other government agencies, issued the Trial Regulations on Centralized Procurement of High-Value Consumable Medical Supplies. These regulations, which...more

China Life Sciences Health Industry Client Briefing – January 2013 (February 21, 2013)

by Vicki Lung, Mao Rong, Gordon B. Schatz, John Tan, May Ling Wong, Jay J. Yan, Katherine Yang, Amy Yin | Reed Smith on 2/22/2013

In This Issue: Li Keqiang Comments from the 12th Plenary Meeting of the Medical Reform Leading Group (USCBC 2012-01-06) – January 6, 2013; MOH Announces Roadmap for Medical Reform (USCBC 2012-01-10) – January 10, 2013;...more

New EU Guidance on Health Claims

by Vanessa Edwards, Sebastián Romero Melchor | K&L Gates LLP on 2/14/2013

Two recent developments of importance for the interpretation of the new list of permitted health claims in the Nutrition and Health Claims Regulation (Regulation 1924/2006 on nutrition and health claims made on foods, "the...more

No Standing for Illegal Drugs: Third Circuit Limits Antitrust Standing for Foreign Drug Manufacturers Absent FDA Approval

by Bill Devinney | BakerHostetler on 2/7/2013

A Third Circuit panel recently ruled that a foreign drug manufacturer lacks antitrust standing when it could only sell its product in the United States through a distributor....more

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Health Law › International Law & Trade

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

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

How to Minimize FCPA Risk in Health Care Acquisitions

Favorable Temporary ACA Exemption for Expatriate Health Plans

Cross-Border Crashes: How Canadian Healthcare Can Affect Your Settlement

US Sues Novartis for Alleged Pharmacy Kickback Scheme

China Life Sciences Health Industry Client Briefing – March 2013 (April 26, 2013)

Focus on Health Care Firms in FCPA Investigations

Health Care Reform Update -- April 2, 2013

Fully-Insured Expatriate Health Plans Get Extra Time to Comply with PPACA

China Clarifies Fast Track Approval Eligibility for Novel Biologics

Capital Thinking Update - March 11, 2013

China Life Sciences Health Industry Client Briefing – February 2013 (March 11, 2013)

News from Abroad: Bill to Diminish Term of Patents for Medicaments

New People's Republic of China (PRC) Regulations for Centralized Procurement of Medical Consumables Contain Significant Penalties...

China Life Sciences Health Industry Client Briefing – January 2013 (February 21, 2013)

New EU Guidance on Health Claims

No Standing for Illegal Drugs: Third Circuit Limits Antitrust Standing for Foreign Drug Manufacturers Absent FDA Approval

January 2013: European Litigation Update

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

Chinese FDA Imposes Mandatory Electronic Barcoding on Imported Drugs

Capital Thinking Update - January 21, 2013

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

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

China Trade Marks – Inclusion of Retail and Wholesale services relating to medicines and pharmaceuticals

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