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Practice Tip: FDA Issues Draft Guidance for REMS Image

Practice Tip: FDA Issues Draft Guidance for REMS

Alan G. Minsk & Lanchi Nguyen

On Sept. 30, 2009, the FDA issued a draft guidance for industry on better understanding and implementing Risk Evaluation and Mitigation Strategies (REMS), which the FDA requires for certain drugs or biologics.

Features

The Alvord Decision: Why Periodic Review of Insurance Policies Is a Must for Franchisors Image

The Alvord Decision: Why Periodic Review of Insurance Policies Is a Must for Franchisors

J. Kevin Cogan & J. Todd Kennard

Franchisors, like other businesses, should periodically review their insurance policies to make certain that they understand the scope of their existing coverage and to identify (and remedy) any significant gaps in that coverage.

Features

Change As a Management and Marketing Tool Image

Change As a Management and Marketing Tool

Bruce W. Marcus

In this economic environment, the word "change" looms large in professional services dialogue. Professions can be fairly rigid and resistant to innovation. But the times seem to have accelerated the need for new ideas and structures to cope with new economic and social problems and opportunities.

Features

Employment Rights of Domestic Violence Victims Image

Employment Rights of Domestic Violence Victims

John D. Shyer & Amy S. Donovan

Several states have enacted laws to protect the employment rights of domestic violence victims, New York among them. Here's why.

Features

Justice Department Issues Guidance on Discovery Image

Justice Department Issues Guidance on Discovery

Jonathan A. Vogel & Elizabeth M.Z. Timmermans

In the wake of a high-profile case that highlighted discovery abuses by federal prosecutors, the Department of Justice (DOJ) issued guidance regarding the government's discovery obligations on Jan. 4, 2010.

Features

Feds to Corporate America: 'The Cops Are Coming' Image

Feds to Corporate America: 'The Cops Are Coming'

Laurence A. Urgenson, Samuel G. Williamson & Audrey L. Harris

On Jan. 19, the Department of Justice (DOJ) announced the arrest of 22 individuals as part of a "sting" operation aimed at uncovering violations of the Foreign Corrupt Practices Act (FCPA). As intended, the case got a great deal of publicity due to both the large number of individuals arrested and the manner in which the investigation was handled.

Features

Three's a Crowd? Image

Three's a Crowd?

Robert J. Ambrogi

Is there room in the legal market for a third high-end legal research service? That is the question as Bloomberg, a company known for its financial news, attempts to muscle in on the turf now occupied by Westlaw and LexisNexis. In December, it officially launched Bloomberg Law.

Features

Ticketmaster Lead Counsel on Live Nation Merger Issues Image

Ticketmaster Lead Counsel on Live Nation Merger Issues

Amanda Bronstad

The proposed merger between Ticketmaster Entertainment Inc. and Live Nation Inc. won Justice Department approval in January 2010, following a year of negotiations. Steven Sletten of Gibson, Dunn & Crutcher counseled Ticketmaster. In an interview, Sletten stated that he prepared his client to face a tough audience, both at the Justice Department and in the court of public opinion.

Features

Trademark Dilution: When 'Minimally Similar' May Be Similar Enough Image

Trademark Dilution: When 'Minimally Similar' May Be Similar Enough

Michael A. Bucci

In <i>Starbucks Corp. v. Wolfe's Borough Coffee, Inc.</i>, the Second Circuit rejected the district court's determination &mdash; based on pre-TDRA case law &mdash; that trademark owners must show "substantial similarity" between the trademarks at issue in order to prevail on a dilution by blurring claim under the TDRA. Citing the language of the TDRA, the appellate court found that the new statute required only "similarity," and that even "minimal similarity" could, in the proper case, suffice to support a claim.

Features

Expansion of Right of Publicity Continues To Create Tensions with First Amendment Image

Expansion of Right of Publicity Continues To Create Tensions with First Amendment

William Sloan Coats & Jennifer P. Gossain

Broadly defined, the right of publicity is a person's right to control the commercial use of his or her identity. It has been over half a century since the term "right of publicity" was first coined by Judge Jerome Frank in 1953. Since that time, courts have been struggling to define the scope of the right of publicity protection, and to resolve the inherent conflicts between the right of publicity and the freedom of expression embodied in the First Amendment.

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