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Read need-to-know updates, commentary, and analysis on Elections & Politics issues written by leading professionals.

Nuevas oportunidades de P3 para tecnología de gobiernos

Si bien las colaboraciones público-privadas (public-private partnerships, P3) se asocian con frecuencia a una infraestructura física, las P3 son esencialmente flexibles y pueden utilizarse para una prestación rentable y...more

Socially Aware: The Social Media Law Update Volume 8, Issue 2

Welcome to the newest edition of Socially Aware, our Burton Awardwinning guide to the law and business of social media. In this edition, we explore the threat to U.S. jobs posed by rapid advances in emerging technologies;...more

What Does the Cures Act Really Mean for Patients?

When signed by President Obama last December, the 21st Century Cures Act—which was the culmination of seven revisions written after the House of Representatives first introduced it in January 2015—was applauded by some as a...more

Appeal for Legislative Action to Address REMS Concerns

by Goodwin on

Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision...more

Arizona Passes Groundbreaking Blockchain and Smart Contract Law – State Blockchain Laws on the Rise

The blockchain or “distributed ledger network” was originally conceived as the peer-to-peer technology platform that allows for the transfer of Bitcoin without the need for a trusted intermediary. However, the blockchain...more

New State Substitution Laws, and a Busy Spring for Biosimilars

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico....more

Trump Targets Tech Teams (And Others) Through H-1B Crackdown

by Fisher Phillips on

President Trump signed an executive order this week directing a full review of the H-1B visa program as part of a continued push to clamp down companies that hire foreign labor instead of American workers. The centerpiece of...more

Brexit – the end of parallel imports from the UK?

by Hogan Lovells on

The United Kingdom's unprecedented vote to leave the EU will undoubtedly cause a broad range of legal issues in the future. This post focuses on the consequences of Brexit on parallel imports - a field of significant...more

New Mexico Becomes 48th State to Enact Data Breach Notification Law

by Ballard Spahr LLP on

New Mexico recently became the 48th state to enact a data breach notification law. This continues the accelerated pace of state data breach legislative activity in the last two years. Since 2015, at least 41 states have...more

New Executive Order Addresses H-IB Visas

by Littler on

On April 18, 2017, President Trump signed the "Buy American and Hire American" executive order (EO), which addresses H-IB visas. The EO calls for the application of existing U.S. laws to visa recipients and the revaluation...more

Buy American and Hire American and the H-1B Lottery

by Franczek Radelet P.C. on

On April 18, President Trump signed an Executive Order labeled the “Buy American and Hire American” initiative. Federal agencies are already subject to certain laws and regulations which require or give preference to American...more

House and Senate Committees Release Draft Bill that Reauthorizes the User Fee Program for Biosimilars

by Goodwin on

The House and Senate Committees released a draft bill on Friday to reauthorize user fee programs for biosimilars, pharmaceuticals, generic drugs, and medical devices from 2018 to 2022. The bill states that the fees authorized...more

Congressional Leaders Seek Input in UFA Reauthorization Draft Bill by April 28, 2017

On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting, these two...more

Top international trade and export control developments in 2017 for ADG companies

by Hogan Lovells on

Aerospace, defense, and government services (ADG) companies increasingly rely on international customers and global supply chains to stay competitive in today’s global market. In the United States, ADG companies rely heavily...more

USCIS H-1B Cap Numbers

by Cozen O'Connor on

The U.S. Citizenship and Immigration Services (USCIS) announced on April 7, 2017 that the agency reached the congressionally mandated number of 65,000 visa H-1B Cap petitions for FY2018. USCIS reported on April 17, 2017 that...more

H-1B Cap Reached; President Trump Signs H-1B Executive Order

On April 7, only five business days into the filing season, U.S. Citizenship and Immigration Services (USCIS) announced that it had already received a sufficient number of H-1B petitions to reach the statutory caps for both...more

Trump Privacy Rollback Continues, States Step Up

by McGuireWoods LLP on

On April 3, 2017, President Trump signed a repeal of new Federal Communications Commission (FCC) rules that would have subjected broadband internet service providers (ISPs) to more stringent consumer privacy regulations....more

Congress Sends Repeal Of Obama-Era Privacy Rules To The White House

by King & Spalding on

Congress has sent repeal legislation (S.J.Res. 34) to the White House to undo the Federal Communications Commission (“FCC”) broadband privacy rules adopted in October 2016 that would have required cable and wireless companies...more

States Take Action! New Mexico, Tennessee and Virginia Pass New Data Breach Legislation

After a quiet winter there has been significant activity in state legislatures to enact, strengthen or clarify their data breach notification statutes. The latest happenings are summarized below and we have updated our “Mintz...more

What’s the State of the Tech Industry? Trump Admin’s Repeal Means Broadband Net Providers and Tech Companies Now Face Consumer...

by Butler Snow LLP on

A recent repeal of federal consumer privacy rules has opened the door to potential sharing and use of sensitive, consumer data with only individual state privacy laws standing in the way....more

Colorado Regulator Proposes New Cybersecurity Rules for Financial Institutions

Increasingly, states are enacting cybersecurity regulations for financial institutions and investment advisors. Following New York’s groundbreaking regulation, Colorado recently proposed changes to its state...more

Trump Administration Announces Changes to the H-1B Program

by Dickinson Wright on

In connection with the Trump Administration’s desire to crack-down on its perceived misuse of the H-1B visa category, various U.S. government agencies have announced a coordinated effort in re-interpreting regulations as well...more

Window on Washington - This Week in the Nation's Capital - Vol. 1, Issue 4

by Clark Hill PLC on

Budget Battles: Amid a recess, lawmakers will miss the April 15 target date for adopting a federal budget outline for the second year in a row. While there are no penalties for missing the April 15 date, a slow start for...more

President Trump Proposes Dr. Scott Gottlieb as FDA Commissioner

by Jones Day on

According to a White House statement, President Trump intends to nominate Scott Gottlieb, M.D., as FDA Commissioner. Dr. Gottlieb has previously served in government in various capacities, including as deputy commissioner for...more

Trump, Gottlieb, and the Cures Act: What Pharmaceutical Manufacturers Need to Know

by Epstein Becker & Green on

The 21st Century Cures Act (“Cures Act”), signed into law by former President Obama on December 13, 2016, sets out a bold agenda for the Food and Drug Administration (“FDA”). Among other things, the Cures Act strives to...more

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