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Arnold & Porter Kaye Scholer LLP
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By Rhiannon Hughes
Following the implementation of the new EudraVigilance system, reported in our previous post, and in an attempt to streamline the monitoring of safety signals in EudraVigilance, the EMA has recently announced that ...
By Laurie Abramowitz, Benjamin Berk, David Sausen, Willys Schneider, C. Sarah Soloveichik
On December 22, 2017, President Trump signed a new tax bill into law, informally referred to as the Tax Cuts and Jobs Act (Tax Act).
By Michael Gerrard, Edward McTiernan
In 2017, New York State enacted multiple laws that tackle aspects of two major environmental issues facing the state: protecting water quality and advancing the state's clean energy goals.
By David Freeman, Jr., Christopher Allen, Michael Mancusi, Brian McCormally, Kevin Toomey
On January 8, 2018, the Federal Deposit Insurance Corporation (FDIC) proposed a revised Statement of Policy (SOP) for Section 19 of the Federal Deposit Insurance Act
By Pari Mody, Kristine Blackwood
While congressional Republicans safely hold the majority, we anticipate strong efforts to advance their legislative agenda.
By Edward Bintz, Jeffrey L. London, Douglas Pelley, Kathleen Wechter
The tax law signed by the President on December 22, 2017 makes a number of changes to the executive compensation rules for public and private companies as well as for non-profit employers.
By Christopher Stothers, Paul Abbott, Kathy Harford, Laura Whiting
This case arose out of a set of circumstances which will not be unusual in the aftermath of the Seattle Genetics decision.
By Craig Holman, Manvin Mayell, Kirk Ogrosky, Debra Schreck, Murad Hussain
This was the lowest annual recovery from government-initiated cases since 2013.
By Mahnu Davar, Nicole Leon, John McInnes
The Final Guidance builds on a regulatory framework that CMS and FDA have developed in collaboration.
By Alan Rothman
With the dismissal of the latter action in Texas, the prerequisite of at least two actions in a total of two federal districts was not met.
By Daniel Kracov, Raqiyyah Pippins, Abeba Habtemariam, Abraham Gitterman, Neha Patel
On December 7, 2017, the FDA announced several digital health policy documents designed to "encourage innovation" and "bring efficiency and modernization" to the agency's regulation of digital health products.
By David Freeman, Jr., Marcus Asner, Michael Mancusi, Brian McCormally, Adam Golodner, Nancy Perkins, Anthony Raglani, Kevin Toomey
On December 12, 2017, the New York Department of Financial Services (DFS) issued four additional frequently asked questions (FAQs) relating to its new cybersecurity regulation (Part 500).
By Roberta Horton
The Court nonetheless reversed the refusal to register "FUCT."
By Nathaniel Castellano
As we approach the fortieth anniversary of the Contract Disputes Act of 1978 (CDA), this foundational waiver of sovereign immunity continues to be riddled with the tell-tale signs...
By Libby Amos, Jacqueline Mulryne, Ian Dodds-Smith
In October, we reported that the oral hearing before the Court of Justice of the European Union took place in Case C-557/16 relating to the role of the Concerned Member States in the Decentralised Procedure.
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