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Online: FDA Web Site Offers Virtual Treasure-Trove
For more information about The Food and Drug Administration's (FDA's) approval for drugs, medical devices and biologics, visit http://www.fda.gov/. The FDA's new mission statement says that the agency is responsible, inter alia, for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation; for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
Hot Topics on the site include: BSE (“Mad Cow Disease”), Ephedra, Imported Drugs, Counterterrorism, Bioterrorism Act, Counterfeit Drugs, and Buying Medicines Online. The information about online prescriptions contains tips and warnings for consumers. For example, purchasing online from an illegal Web site puts the purchaser at risk. He or she may receive a contaminated or counterfeit product, the wrong product, an incorrect dose, or no product at all. Additional risks include potentially dangerous drug interactions and other serious health consequences.
Click on “Drugs” and you'll find yourself at the site for the Center for Drug Evaluation and Research (CDER). News from the CDER includes two March 22 items: one from the FDA and Lilly notifying health care professionals about a revision to the WARNINGS section of labeling, describing the increased risk of hyperglycemia and diabetes in patients taking Zyprexa. There is a link to MedWatch Safety Info for further information. A second item requested a warning statement in labeling for certain antidepressants to encourage close observation for worsening depression or the emergence of suicidality. There are two March 17 items: one approving the first-time generic Desferal for Injection for the treatment of acute iron intoxication or chronic iron overload, the other approving first-time generic Naproxen Sodium and Pseudoephedrine Hydrochloride Extended-release Tablets for the temporary relief of these cold, sinus and flu symptoms: sinus pressure, minor body aches and pains, headache, fever, nasal and sinus congestion.
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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 Stranger to the Deed Rule
In 1987, a unanimous Court of Appeals reaffirmed the vitality of the "stranger to the deed" rule, which holds that if a grantor executes a deed to a grantee purporting to create an easement in a third party, the easement is invalid. Daniello v. Wagner, decided by the Second Department on November 29th, makes it clear that not all grantors (or their lawyers) have received the Court of Appeals' message, suggesting that the rule needs re-examination.