Jeffrey Orenstein

Jeffrey Orenstein

Reed Smith

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Medical Device Companies Face Severe FCA Penalties for TAA Violations

A spate of recent multi-million dollar settlements has shown that medical device manufacturers are subject to substantial liability under the False Claims Act (FCA) if they misstate the country of origin of their products in...more

3/19/2015 - Enforcement Actions False Claims Act Manufacturers Medical Devices Trade Agreements Act

BIS Addresses 'Commingling' in Crude Oil Exports

On December 30, 2014, the U.S. Department of Commerce, Bureau of Industry and Security (“BIS”) issued its first-ever published guidance on the Short Supply Controls, the regulations that limit the export of crude oil out of...more

1/8/2015 - BIS Commingling Export Controls Exports New Guidance Oil & Gas U.S. Commerce Department

BIS Issues First Published Guidance on the Short Supply Controls

Today, the U.S. Department of Commerce, Bureau of Industry and Security (“BIS”) issued the first-ever published guidance on the Short Supply Controls, the regulations that limit the export of crude oil out of the United...more

1/2/2015 - BIS EAR Export Controls New Guidance Oil & Gas

Condensate Exports Raise Compliance Questions for Purchasers

Recent press reports covering the sale and export of lightly processed condensate from the Eagle Ford Shale have characterized such transactions as a major test to the four-decade-long ban on crude oil exports, and a sign...more

11/10/2014 - BIS Canada Chief Compliance Officers Eagle Ford Shale EAR Exports Oil & Gas

‘Country of Origin’ Compliance: The Top 10 Things Pharmaceutical Companies Need to Know

What is the “country of origin” for the drugs you manufacture? This question arises every time a pharmaceutical company labels a drug, imports it, exports it, markets it, or sells it to the U.S. government. Unfortunately, the...more

2/7/2014 - Compliance Country of Origin Pharmaceutical Prescription Drugs

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