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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.
Legal Possession: What Does It Mean?
Possession of real property is a matter of physical fact. Having the right or legal entitlement to possession is not "possession," possession is "the fact of having or holding property in one's power." That power means having physical dominion and control over the property.
The Stranger to the Deed Rule
In 1987, a unanimous Court of Appeals reaffirmed the vitality of the "stranger to the deed" rule, which holds that if a grantor executes a deed to a grantee purporting to create an easement in a third party, the easement is invalid. Daniello v. Wagner, decided by the Second Department on November 29th, makes it clear that not all grantors (or their lawyers) have received the Court of Appeals' message, suggesting that the rule needs re-examination.