Members of our Government Investigations & White Collar team recently presented a timely webinar on the new Foreign Extortion Prevention Act (FEPA). The Act, which has been referred to as “the most consequential anti-foreign-bribery law passed in almost 50 years,” allows the DOJ to prosecute foreign officials who demand or accept a bribe from a … Continue Reading
Along with the Federal Association of the Pharmaceutical Industry (BPI), the American Chamber of Commerce in Germany and the Federal Association of German In-house Lawyers (BUJ), we cordially invite you to attend our Life Sciences Day on 20 September 2018 in Frankfurt. The trend for public and private healthcare systems over the past few years … Continue Reading
On 7 June, the UK’s Competition Appeal Tribunal (CAT) annulled in part a decision by the UK’s Competition and Markets Authority (CMA) imposing fines of nearly £90 million on two pharma companies, Pfizer and Flynn, for charging excessive prices for the anti-epileptic drug, phenytoin sodium capsules. The case is notable as it marks the first … Continue Reading
Last month, the U.S. Department of Health and Human Services (HHS) entered into a historic Memorandum of Understanding (MOU) with Cuba’s Ministry of Public Health. The MOU establishes coordination across a broad spectrum of public health issues, including: Healthcare systems and public health management; Quality management and patient safety systems in hospitals and outpatient settings; … Continue Reading
On May 25, 2016, the European Union (“EU”) Council and Parliament politically agreed on the provisions that will go into the final version of the long-awaited EU medical device and in vitro diagnostic (“IVD”) regulations. The agreement seeks to fill the regulatory gaps uncovered as technology evolved faster than the current regulatory regime, which had … Continue Reading
The Food and Drug Administration (FDA) requested comments on March 4 regarding definitions and possible regulations governing medical device refurbishers, reprocessors, and other third parties. Medical device manufacturers have the duty, under 21 C.F.R. Part 820, to provide instructions to third parties that may service or install their products. However, manufacturers may not be able … Continue Reading
The World Economic Forum has identified that today’s global infrastructure demand is estimated at approximately US$ 4 trillion in annual expenditures, with a gap – or missed opportunity – of at least US$ 1 trillion every year. Despite existing supply of private capital, much more is needed to fill this gap. This demand for infrastructure … Continue Reading
