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News from the FDA
Approval of Currently Unapproved Medicines
On Oct. 17, the FDA announced that it will aggressively crack down on the marketing of unapproved drug products. At the same time, the agency proposed new steps to assure the safety and efficacy of certain unapproved but widely marketed medicines. These unapproved drugs include medicines that were developed and marketed before modern standards for drug approval were established. The keystone to this effort is a draft Compliance Policy Guide (CPG) the agency is issuing outlining FDA policies to encourage companies to sponsor these drugs through the approval process. Many of the potentially beneficial drugs in this category could be approved based on straightforward scientific data that would not involve conducting new clinical studies of safety and effectiveness (eg, peer-reviewed medical literature, or other existing data), the FDA stated.
The draft Compliance Policy Guide is posted on the Internet at http://www.fda.gov/cder/guidance/5704dft.pdf.
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.