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Features
The first part of this article discussed the background of REMS (Risk Evaluation and Mitigation Strategies) and provided a summary of the Draft Guidance. The conclusion herein explains the second part of the procedure, including proposed modifications and communicating with the FDA.
Features
So many contracts contain the phrase "in accordance with generally accepted accounting principles," but do lawyers really understand what this phrase means or how it may affect a client in any given contract?
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Taxpayers with unreported foreign bank accounts are sweating bullets these days. The IRS is in the midst of an unprecedented crackdown on foreign bank accounts.
Features
A broad survey of Federal Trade Commission ("FTC") actions and appointments throughout 2009 reveals priorities in enforcement efforts. For instance, the FTC initiated what some observers characterize as fundamental changes to its previous modus operandi ' changes that mark a more proactive approach on several fronts.
Features
e-Commerce entrepreneurs need many skills to succeed. First, they must have the technical chops to build and run a superior site. Next, they must market that site to stand out among the many competitors in a crowded market. They must also know enough about business to do all the above profitably. And since no one person can do all of these things well, nearly all of these entrepreneurs must be able to evaluate and hire people with all these skills. That is, until the day comes to sell the business ' the Holy Grail of the dot-com boom. Then, a whole new set of skills is required.
Features
On Sept. 30, 2009, the FDA issued a draft guidance for industry on better understanding and implementing Risk Evaluation and Mitigation Strategies (REMS), which the FDA requires for certain drugs or biologics.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 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
On the one hand, companies want to capture the attention of potential customers roaming the social media space. On the other hand, conversations in the blogosphere are largely uncontrollable, and raise a myriad of risks. Social media can cause serious losses if not handled correctly.
Features
As the nation's first case involving criminal prosecutions of teenagers for "sexting" made its way to a federal appeals court in Philadelphia, all three judges seemed skeptical of the prosecutor's claim that child pornography laws are violated when a teen transmits a nude image of herself.
Features
The Internet Corporation for Assigned Names and Numbers ("ICANN") plans to issue generic top-level domain names ("gTLDs") beyond the current 21 top-level domain names ("TLDs") such as .com and .net. For the first time, trademark owners may use their marks as gTLDs; for example, .nike. The application process is complex, and trademark owners have no guarantee that they will secure gTLDs for their marks. e-Commerce providers, however, can use trademark-law strategy to gain advantages during the application process.