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January 17, 2017, Covington Alert

On January 13, 2017, the U.S. Food and Drug Administration (FDA or Agency) released a discussion paper synthesizing public feedback on FDA’s 2014 draft guidance documents and outlining a possible approach to regulation of laboratory developed tests (LDTs) (Discussion Paper). This approach is intended to “advance the public discussion by providing a possible ...

January 13, 2017, Covington Alert

Over the past few months, the agencies responsible for criminal and civil enforcement of U.S. export control and economic sanctions laws have implemented a number of important changes in their enforcement practices. In October 2016, the U.S. Department of Justice (“DOJ”), National Security Division (“NSD”) published guidance on voluntary self-disclosures of ...

January 13, 2017, Covington Alert

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 11, 2017, Covington Alert

Late last week, a group of technology industry leaders, researchers, and former policymakers comprising the President’s Council on Science and Technology (“PCAST”) issued a report entitled Ensuring Long-Term U.S. Leadership in Semiconductors. The report concludes that China is seeking to reshape the global semiconductor industry in a manner that threatens U.S. ...

January 10, 2017, Covington Alert

“Call the office asap!” Those may be the most feared words in the English language for Chiefs of Staff to Members of Congress. This primer covers what to do when that call reveals that a Member or staffer is under federal investigation.

January 10, 2017, Life Sciences Intellectual Property Review

January 10, 2017, Medtech Showcase

January 10, 2017, Bloomberg BNA Federal Contracts Report