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January 17, 2017, Global Policy Watch

The House of Representatives is not in session this week for legislative business.  The Senate faces a shortened week, with the observance of the federal holiday marking the birthday of Martin Luther King, Jr. on Monday, January 16, and the inauguration of Donald Trump as President set for Friday, January 20. The Senate returns to legislative … Continue Reading

January 16, 2017

LONDON—Craig Pollack and Louise Freeman have joined Covington as partners in the firm’s European Dispute Resolution practice resident in London. Mr. Pollack will also serve as co-chair of the firm’s Global Disputes Initiative with former U.S. Attorney General Eric Holder and former U.S. Under Secretary of State Alan Larson.  Mr. Pollack focuses on complex high ...

January 15, 2017, Inside Medical Devices

In 2016, the Office of Compliance at the U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health issued a total of 17 warning letters to medical device manufacturers citing violations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping.  The 2016 warning letters inform current … ...

January 14, 2017, Cov Africa

In response to “positive actions” taken by the Government of Sudan over the past six months, the U.S. Department of the Treasury’s Office of Foreign Assets Control (“OFAC”) announced today an amendment to the Sudanese Sanctions Regulations (“SSR,” 31 C.F.R. Part 538) that effectively suspends virtually all of the U.S. sanctions against Sudan by authorizing … ...

January 14, 2017, Inside Privacy

By Christopher Hanson On December 28, 2016, CDRH announced the publication of the final guidance “Postmarket Management of Cybersecurity in Medical Devices.”  In a separate post, we reported on the January 22, 2016 draft version of this guidance document.  The final guidance provides FDA’s recommendations on a risk-based framework for medical device ...

January 13, 2017, Global Policy Watch

Summary Next week is an important plenary in Strasbourg, as Member of the European Parliaments (“MEPs”) will elect their future President, Vice-Presidents, and Quaestors. New elected officials will remain in office for two and a half years. Though the official list of candidates running for the Presidency will only be announced on Monday, a number … Continue ...

January 12, 2017, Inside Government Contracts

Among the many subjects to receive President-elect Trump’s attention in advance of his swearing in on January 20 are venerable defense contractors and their performance of major systems contracts.  The Boeing Company (Boeing) and Lockheed Martin (Lockheed) have both felt the “heat of the tweet” – Boeing for the projected cost of the next generation … Continue ...

January 12, 2017, Inside Government Contracts

A few weeks ago, we provided a few tips for negotiating and assessing a release contained in a contract modification, and discussed why the Civilian Board of Contract Appeals (CBCA) found that a global release contained in one of many contract modification was ambiguous. Now, we consider a different scenario: what happens when a final … Continue Reading The post ...

January 12, 2017, Global Policy Watch

Brexit, the EU’s Response, and a Focus on Defense On December 15, at the end of their traditional end of the year European Council, the 27 “remaining” EU heads of state or government had a short meeting, without Theresa May, to set out how the EU will handle the Brexit process once the UK has notified … Continue Reading

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