International Law & Trade, Administrative Law, Health Law

"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

2013 Enforcement Predictions

by Michael Volkov on 1/14/2013

I always like to make predictions at the beginning of each year. My track record is plus and minus – sometimes on target, sometimes off-target. The biggest story in the last five years has been the rise of FCPA...more

Corporate and Financial Weekly Digest - December 21, 2012

by Katten Muchin Rosenman LLP on 12/24/2012

In this issue: - Nallengara to Replace Cross as Corp. Fin. Chief - FINRA Rule Relating to Private Placements of Securities Effective December 3 - Additional Guidance on FINRA’s Suitability Rule - No-Action...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

China Life Sciences and Health Industry Client Briefing – October 2012 (November 16, 2012)

by Reed Smith on 11/20/2012

In This Issue: - China Becoming Healthcare R&D Hub (China Daily 2012-10-09) – October 9, 2012 - Imported Drugs to Go on China's Electronic Monitoring Network (Xinhua News Agency 2012-10-08) – October 9, 2012...more

China Issues Human Genetic Resources Management Regulations

by Foley & Lardner LLP on 11/19/2012

Those seeking to conduct research involving human genetic material within the People’s Republic of China or to import into China such material should review China’s recently issued draft regulations (“Draft”) for the...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

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

Obama Extends Critical Immigration Programs

by Cox Smith on 10/8/2012

Critical EB-5 Regional Center, E-Verify, and Physician Conrad 30 Programs Reauthorized Until September 30, 2015 - Foreign Physicians Face New Licensure Hurdles On September 28, 2012, President Obama signed into law S....more

Under the Dome: Inside the Maine State House 9.21.12

by Pierce Atwood LLP on 9/24/2012

Under the Dome: Inside the Maine State House provides a high-level overview of recent activity at the Maine State House. If you would like more specific information regarding an item in this newsletter or related to...more

‘Health Claim’ Definition to Be Interpreted Widely, EU Court Rules

by K&L Gates LLP on 9/10/2012

In its first judgment on Regulation 1924/2006 on nutrition and health claims made on foods, the Court of Justice of the EU adopted a broad interpretation of the definition of “health claim” by ruling that claims for merely...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

Baker & McKenzie: Government Procurement in the Health Sector under the Australia – United States Free Trade Agreement (FTA)

by Baker & McKenzie Australia on 8/7/2012

This alert provides an outline of procurement practices that Australian public sector health bodies should be applying in their procurements to give effect to obligations under the FTA. We address three questions: ? ...more

International Employment Law Review - July 2012 / Issue 2

by Dechert LLP on 7/23/2012

Welcome to the latest issue of the International Employment Law Review. In this edition, we examine the most significant employment law developments of the year thus far in Belgium, England and Wales, France, Germany,...more

Medical Device Manufacturer Resolves FCPA Violations Related to Conduct in Mexico

by BuckleySandler LLP on 7/17/2012

On July 10, medical device manufacture Orthofix International N.V. became the latest in a string of companies in the medical device sector to resolve an FCPA matter with the U.S. government....more

India's New Biosimilar Guidelines and Their Relationship to the Rest of the World

by Dechert LLP on 7/17/2012

The Indian Ministries of Health & Family Welfare and Science and Technology have released their Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India (the “Indian Guidelines”). These...more

“But what is it, Doc?” – Health Care Professionals under Professionals under Regulation 1924/2006

by K&L Gates LLP on 7/5/2012

Changes in the epidemiological profile in Western countries during the last three decades have shown an increasing trend in the development of non-transmissible chronic diseases in the adult population. Nutrition-related...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

High Noon: The Italians try to play solo the Health Claims game

by K&L Gates LLP on 7/5/2012

On November 27, 2009, the Italian Government notified a draft regulation on the use of substances other than vitamins and minerals in food supplements before the European Commission, pursuant to the procedure laid down in...more

Criminal Drug Company Glaxo is Slapped on the Wrist

by Lawyers.com on 7/5/2012

After six years of bribing American doctors, pushing antidepressants on children and hiding the heart attack risk of a diabetes drug, the British drug Company GlaxoSmithKline LLC got a slap on the wrist yesterday....more

Data Protection in Clinical Studies – Implications of the New EU General Data Protection Regulation

by K&L Gates LLP on 6/20/2012

The European Commission published in January 2012 a proposal for a regulation setting out a general framework for data protection. The proposal, after adoption, shall supersede the current Data Protection Directive with a...more

Life Sciences Health Industry China Briefing – May 2012 (June 14, 2012)

by Reed Smith on 6/15/2012

In This Issue: News - Introduction of Administrative Measures on Clinical Application of Antimicrobial Drugs (Ministry of Health 2012-05-08) – May 9, 2012 The Ministry of Health recently issued the...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

China Briefing - April 2012 (May 21, 2012)

by Reed Smith on 5/22/2012

Pharmaceuticals, Medical Devices, Health Care & Life Sciences News • NDRC: Chinese government to review carefully drug pricing differences between ex-factory and bid prices (NBD News 2012-04-05) – April 5, 2012...more

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International Law & Trade › Administrative Law › Health Law