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February 15, 2018, Covington Alert

On December 20, 2017, the Senate and the House voted to pass the conference version of H.R. 1, the Tax Cuts and Jobs Act (the “Act”), and President Trump signed the bill into law on December 22, 2017. Below, we summarize those provisions of the tax reform legislation that are most likely to be of particular interest to political action and tax-exempt ...

February 14, 2018, Covington Alert

The Tax Cuts and Jobs Act of 2017 (the “Act”) became Pub. Law 115-97 on December 22, 2017. Many of its more startling provisions have become well known since then. Of less dramatic impact are several provisions affecting qualified employer plans, fringe benefits, and certain kinds of compensation. These provisions are described in this client alert. This client ...

February 9, 2018, Covington Alert

This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.

February 2, 2018, Covington Alert

On Wednesday, January 31, 2017, the D.C. Circuit, sitting en banc, issued its long awaited decision in PHH v. CFPB, holding that the Bureau’s structure is constitutional and overruling an earlier decision that would have permitted the President to replace the Bureau’s Director at will.

February 1, 2018, Covington Alert

This International Employment Update summarises recent international employment law developments in China, India, Italy, Russia, the United Kingdom, and the United States.

January 31, 2018, Covington Alert

In the EU, a sponsor can obtain an “orphan designation” for a medicinal product pursuant to Regulation 141/2000. Adopted in December 1999, the regime aims to encourage investment in R&D for treatments for rare diseases. The most important incentive is the 10-year market exclusivity for designated products. Other incentives include protocol assistance and fee ...

January 30, 2018, Covington Alert

Last week (January 24, 2018), FDA issued a series of guidance documents and an enforcement discretion policy intended to help the food industry comply with the requirements of the Food Safety Modernization Act (FSMA). The documents further FDA’s goal to ensure that all food under its jurisdiction is produced under procedures that comply with its risk-based food ...

January 26, 2018, Covington Alert

We are writing to report on the latest significant developments in the effort to reform the Committee on Foreign Investment in the United States (“CFIUS”).

January 26, 2018, Covington Alert

This e-alert reviews trends emerging from warning letters and untitled letters concerning therapeutic product advertising and promotion issued in 2017 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER), the Office of Compliance and Biologics Quality (OCBQ) of the Center for Biologics Evaluation and Research ...