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News from the FDA
New Rules On Development of Veterinary Drugs That Can Affect Food Supplies
Of interest to veterinary medicine manufacturers is a final guidance document issued by the FDA titled “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing” (VICH GL28). The guidance was adapted for veterinary use by the International Cooperation on Harmonisation of Technical Require-ments for Registration of Veterinary Medicinal Products (VICH) from a guidance regarding pharmaceuticals for human use. It's intended to help ensure that residues of veterinary drugs in animal products for human consumption are not too carcinogenic and applies to food in the European Union, Japan, and the United States. Copies of the document may be obtained on the Internet from the CVM home page at http://www.fda.gov/cvm. For more information, see Docket No. 2001D-0357 at http://a257.g.akamaitech.net/ 7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-11781.htm
Botanical Drug Product Approval Process Outlined
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?