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News from the FDA
Delay of Effective Date: PDMA and Prescription Drug Amendments of 1992
Because the FDA is working with stakeholders through its counterfeit drug initiative to encourage widespread, voluntary adoption of track-and-trace technologies that will generate a de facto electronic pedigree, including prior transaction history back to the original manufacturer, as a routine course of business, the agency is delaying the effective date of Sections 203.3(u) and 203.50 (21 CFR 203.3(u) until Dec. 1, 2007. The delay will allow stakeholders a chance to continue to move toward the goal of universal use of track-and-trace technology, which, if widely adopted, will help fulfill the pedigree requirements of the Prescription Drug Marketing Act of 1987 (PDMA) and obviate or resolve many of the concerns that have been raised with respect to the final rule by ensuring that an electronic pedigree travels with a drug product at all times.
Final Rule Issued on Bar Code Label Requirements
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.
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.
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.
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?