Alerts

The US Food and Drug Administration (FDA) recently issued a draft guidance entitled “Transfer of a Premarket Notification (510(k)) Clearance — Questions and Answers — Draft Guidance for Industry and Food and Drug Administration Staff.”

In September 2014, Arent Fox reported about a US court case with which every corporate officer of a company doing business in the United States should become familiar.

The US Food and Drug Administration (FDA) recently issued a draft guidance document announcing that it does not intend to regulate low-risk products intended for general wellness only as medical devices.

Many companies and other stakeholders have chosen to participate in the United Nations (UN) Global Compact as a means of demonstrating their commitment to integrating universal Corporate Social Responsibility (CSR) principles into their business practices.

Arent Fox filed an amicus brief for the Law Center to Prevent Gun Violence in the 9th Circuit matter Teixeira v. County of Alameda.

Foreign Corrupt Practices Act (FCPA) violations can lead to significant collateral consequences.

The last decade has seen enormous growth in the human tissue products industry, following the Food and Drug Administration’s establishment, in 2001, of a tiered approach to the regulation of these products (referred to as “human cells, tissues and cell- and tissue-based products,” or “HCT/Ps”).

On January 12, 2015, California’s Office of Environmental Health Hazard Assessment (OEHHA) issued a proposed regulation to revise the required warning statement for products containing chemicals listed by the state under Proposition-65 (Prop-65).

Your company has been asked by a customer to certify that its products manufactured in US plants are in compliance with “Buy American” requirements. How does your company respond?

Your company has been asked by a customer to certify that its products manufactured in US plants are in compliance with “Buy American” requirements. How does your company respond?

In a succinct eight-page opinion, the Supreme Court ruled unanimously last week that trademark “tacking” is a question of fact that should generally be decided by juries.

The Food and Drug Administration (FDA) has just issued its long-awaited Draft Guidance on Current Good Manufacturing Practice (CGMP) Requirements for Combination Products.

In 2014, the Departments of State and Commerce implemented final rules that overhauled 11 United States Munitions List (USML) Categories. These changes have affected a wide range of industries.

Most parties that enter into arbitration agreements do not expect their choice to be diminished by being forced to litigate in open court. This paramount deference to contractual freedom is a hallmark of US law as well as the practice in the United States Court of Appeals for the Second Circuit.

On January 16, 2015, Sens. Jerry Moran (R-KS) and Mark Warner (D-VA) introduced S. 181 (The Startup Act), which is meant to promote new business formation, especially in the information technology industry.

The Treasury Department’s Office of Foreign Assets Control and the Commerce Department’s Bureau of Industry and Security released their much-anticipated regulations governing trade with Cuba, and they were published in the Federal Register and became effective on January 16, 2015.

On January 15, 2015, the Federal Communications Commission’s (FCC) Notice of Proposed Rulemaking (NPRM) regarding the scope of its definition of “multichannel video programming distributors” (MVPDs) was published in the Federal Register.

Should you choose federal litigation or arbitration? In arbitration, parties to a dispute agree to submit the dispute for a decision to a neutral third party who is not a public official. Advantages include limited discovery while disadvantages include narrower grounds for appeal.

Late last week, eight days after the Terrorism Risk Insurance Act (TRIA) expired, the US House of Representatives and the US Senate overwhelmingly approved H.R. 26, legislation reauthorizing TRIA until the end of 2020.

In a precedential ruling, the Trademark Trial and Appeal Board of the US Patent & Trademark Office (USPTO) sustained an opposition by McDonald’s to the mark MCSWEET for pickled gourmet vegetables on the grounds that it infringed on and diluted McDonald’s famous family of “MC” for formative marks.

Canada’s Department of Foreign Affairs, Trade, and Development announced an enhanced Corporate Social Responsibility Strategy when it released a report entitled “Doing Business the Canadian Way: A Strategy to Advance Corporate Social Responsibility in Canada’s Extractive Sector Abroad.”

On December 30, 2014, Michigan Governor Rick Snyder (R), signed Public Law 414 into law, which excludes college athletes from the definition of “public employees” who are entitled to collectively bargain in Michigan.

Following up from the Executive Order 13685 which effectively banned US trade and investment with Crimea, the Department of the Treasury has just issued General License 5.

TRUSTe, Inc., a major provider of privacy certifications for online businesses, recently settled with the Federal Trade Commission (FTC) over charges that it has been engaging in deceptive business practices.