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Counterfeit Drugs: FDA Suggests New Counter Measures
The FDA's Counterfeit Drug Task Force issued its interim report on October 2. It contains potential options for a multi-pronged approach to combat counterfeit drugs. In recent years, the FDA has seen an increase in the number and sophistication of efforts to introduce counterfeit drugs. The FDA noted at the time the report was issued that the problem of counterfeit drugs is being treated separately from the problem of unapproved and potentially unsafe drugs that are being imported via the Internet and other unregulated international channels. Under current law, those drugs are purchased outside of U.S. and foreign consumer protection systems, so they are “buyer beware” products that have traveled outside of the regulatory protections of the legal U.S. drug distribution system.
Final Report Due Soon
The Task Force's final report on ways to combat drug counterfeiting is due in early 2004. The potential options in the interim report were premised on three interim conclusions: 1) There is no single “magic bullet” against the growing number of sophisticated counterfeiters; rather, a multi-pronged strategy to secure the drug supply could be much more difficult for counterfeiters to overcome than any single method; 2) Although drug counterfeiters today are more sophisticated and better organized than ever before, there are many new technologies and approaches that have the potential to prevent and contain counterfeit drug threats; and 3) Because many of these promising ideas have not been fully developed, the Task Force will need to seek broad public comment to guide its further work.
Major Differences In UK, U.S. Copyright Laws
This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.
The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
Strategy vs. Tactics: Two Sides of a Difficult Coin
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
Removing Restrictive Covenants In New York
In Rockwell v. Despart, the New York Supreme Court, Third Department, recently revisited a recurring question: When may a landowner seek judicial removal of a covenant restricting use of her land?
"Holy Fair Use, Batman": Copyright, Fair Use and the Dark Knight
The copyright for the original versions of Winnie the Pooh and Mickey Mouse have expired. Now, members of the public can create — and are busy creating — their own works based on these beloved characters. Suppose, though, we want to tell stories using Batman for which the copyright does not expire until 2035. We'll review five hypothetical works inspired by the original Batman comic and analyze them under fair use.