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November 21, 2017, Covington Alert

In a July 7, 2017 post to the FDA Voice blog, FDA Commissioner Scott Gottlieb announced that FDA would be releasing a “comprehensive regulatory framework” for regenerative medicine products. On November 16, 2017, FDA issued four guidance documents outlining certain aspects of that framework. This alert summarizes each of the guidance documents and highlights ...

November 20, 2017, Webinar

November 17, 2017, Covington Alert

Earlier this week, FDA issued a long-anticipated draft guidance on best practices to follow when convening an expert panel to evaluate whether a substance is “generally recognized as safe,” or GRAS, under the conditions of its intended use in food.

Medical Food Summit

Presentation and Speech

November 16, 2017, Capital Hilton, Washington, DC

November 13, 2017, Covington Alert

On November 7, 2017, the U.S. Department of Justice (“DOJ”) unsealed criminal charges against five individuals in connection with an alleged bribery scheme to assist Rolls-Royce plc (“Rolls-Royce” or the “Company”) in obtaining a US $145 million government contract to supply equipment and services for a gas pipeline from Kazakhstan to China.   

November 13, 2017, Covington Alert

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) published the long-awaited 2019 Notice of Benefit and Payment Parameters, which includes significant changes to the implementation regulations of the Affordable Care Act (ACA). 82 Fed. Reg. 51,052 (Nov. 2, 2017).

November 13, 2017, Covington Alert

On Thursday, November 9, 2017, the U.S. Departments of Treasury and Commerce published regulatory amendments that impose new restrictions on financial, travel, and trade-related transactions with Cuba by persons subject to U.S. jurisdiction.

November 10, 2017, American Bar Association


Presentation and Speech

November 9, 2017, CTIA Wireless Legal Seminar for the West