All Perspectives

The US Food and Drug Administration (FDA) recently issued a draft guidance entitled “Transfer of a Premarket Notification (510(k)) Clearance — Questions and Answers — Draft Guidance for Industry and Food and Drug Administration Staff.”

Arent Fox LLP secured a summary judgment on behalf of the sportswear manufacturer Fila against a website that was cybersquatting.

The US Food and Drug Administration (FDA) recently issued a draft guidance document announcing that it does not intend to regulate low-risk products intended for general wellness only as medical devices.

Focus Education, LLC, a leading provider in the growing market for cognitive improvement products, recently settled with the Federal Trade Commission (FTC) over charges that it was misleading consumers through the use of deceptive advertising tactics.

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 Federal Trade Commission (FTC) released a report this week examining the privacy and security implications of the so-called “Internet of Things.”

In this episode of Fashion Counsel, Partner Anthony Lupo talks with Partner Kelli Scheid Smith about tactics fashion brands should think about when they’re expanding into e-commerce including potential issues with distributor agreements.

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).

For almost 30 years, hospitals and certain other health care organizations have been required to report to the National Practitioner Data Bank (NPDB) specified “adverse actions” regarding  physicians and dentists that they employ, contract with, or have on staff.

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.

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.

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.

The Food and Drug Administration (FDA) has just issued its long-awaited Draft Guidance on Current Good Manufacturing Practice (CGMP) Requirements for Combination Products.

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?

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.

Recent guidance from Hong Kong’s Privacy Commissioner suggests that Hong Kong may be on the verge of implementing major new restrictions on the cross-border transfer of personal data.

Arent Fox International Arbitration & Dispute Resolution partner Timothy J. Feighery wrote an opinion article published by Roll Call that outlined potential next steps for US businesses and private citizens to secure payment on $1.8 billion in unpaid claims against Cuba.

Arent Fox expands Government Relations practice with addition of Senior Government Relations Director Alex Manning. Alex is joining the firm’s Washington, DC office and will advise clients on issues surrounding cybersecurity, privacy, data breaches, tax, trade policy, and immigration.

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.

Arent Fox International Arbitration & Dispute Resolution partner Timothy J. Feighery was interviewed by Mike Vitoria, host of the radio program On the Money, about the United States’ normalizing of diplomatic relations with Cuba.

The beginning of 2015 brings implementation of The Joint Commission’s (TJC) newly rewritten Sentinel Events Policy (Policy) for hospitals. Released in late 2014, and effective January 1, 2015, the Policy clarifies and puts into operation new and revised definitions and expectations.