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Practice Tip: The Physician Labeling Rule
On June 30, 2006, new regulations governing the format and content of prescription drug labels went into effect. These changes marked the first major overhaul of drug labeling rules in more than 25 years.
The primary purpose of the changes is to make labels more accessible to practicing physicians. When the FDA first issued the rule in December 2000, it expressed concern that product labels had become too cluttered as a result of growing chemical complexity of drugs and the effects of product liability litigation. The new label, including a 'highlights' section, a table of contents, and a streamlined adverse reaction section, is designed to return the product label to its originally intended purpose as a useful and clear tool for practicing physicians.
In issuing the final rule, the FDA clearly staked out its position that these new rules are intended to clarify long-standing principles regarding product labeling, what should (and should not) be in a label, and the FDA's role in approving label changes. As part of this statement, the FDA reiterated its position that approved labels generally pre-empt state tort lawsuits that claim a different label (or warning) was appropriate. The details of these pre-emption issues are the subject of much litigation and not the central focus of this article.
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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.