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A Regulatory Lawyer's Perspective: The FDA's Guidances on Risk Assessment, Minimization and Management
In the pharmaceutical industry, due to all types of business pressures and constraints, it is not atypical for a company to behave reactively and in triage-mode, rather than considering proactive steps that it can take in the compliance arena. In 2005, the Food and Drug Administration (“FDA”) issued three final guidance documents to help focus the industry and encourage companies to consider more thoughtfully and thoroughly the issues of quality risk assessment, minimization, and management collectively.
Background
The guidances are not law. They do not bind the FDA or the industry. However, the guidances reflect the agency's current thinking, and it would be foolish not to review the FDA's playbook. At a minimum, they should be considered best industry practices.
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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 Anti-Assignment Override Provisions
UCC Sections 9406(d) and 9408(a) are one of the most powerful, yet least understood, sections of the Uniform Commercial Code. On their face, they appear to override anti-assignment provisions in agreements that would limit the grant of a security interest. But do these sections really work?