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Drug & Device News
GAO Finds FDA's Safety Tracking System Lacking
A report issued in December by the Government Accountability Office (GAO), faults the U.S. Food and Drug Administration's (FDA's) management of postmarket drug safety information. The FDA is supposed to keep track of postmarket studies and other data concerning safety problems with FDA-approved medications that have entered the market, but its current systems are apparently inadequate for this purpose. According to the report, “Internal control standards for federal agencies specify that information should be recorded in a form and within a time frame that enables staff to carry out their responsibilities and that relevant, reliable, and timely information should be available for external reporting purposes. However, evaluations conducted by CDER (Center for Druge Evaluation) of data in its database revealed problems with the completeness, timeliness, and accuracy of the data.” Because of these inadequate systems, data is not being recorded and made accessible in a way that would allow the FDA to publish statutorily required reports on potential drug safety issues.
According to the report, the FDA agrees with the GAO's findings and is working to improve its systems to address its concerns.
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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?