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News from the FDA
Electronic Submissions Draft Guidance Available
“Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submission,” a draft guidance for industry, is one in a series of guidance documents on providing regulatory submissions to the FDA in electronic format. The guidance discusses issues related to the electronic submission of new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics licensing applications (BLAs), investigational new drug applications (INDs), master files, advertising material, and promotional labeling. The agency predicts that submission of these documents in electronic format will improve its efficiency in processing, archiving, and reviewing them.
Submit written or electronic comments on the draft guidance by October 28 to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
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.
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?
The Cost of Making Partner
Making partner isn't cheap, and the cost is more than just the years of hard work and stress that associates put in as they reach for the brass ring.