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Drug Compounding: Many Considerations
The tug-of-war pitting patients against pharmaceutical companies against pharmacists selling competing compound drug mixtures to the public has lately gained greater urgency. Pharmaceuticals manufacturers contend that once their branded medications have been approved by the FDA, compounded concoctions that replicate them should not be permitted, as they are not subject to the same high safety standards and inspection requirements of the branded drugs. Consumers and pharmacists, among others, claim such arguments mask a different Big Pharma goal: the pursuit of high profits at the expense of patient access to affordable medications.
Now, a nationwide outbreak of fungal meningitis, likely caused by one component of a compounded drug, is altering the dialog. The suspect product in this instance is an injectable steroid, preservative-free methylprednisolone acetate (80mg/ml), which was produced by New England Compounding Center (NECC), in Framingham, MA. It was distributed across the country to pain clinics, which administered it to an estimated 13,000 patients. As of Oct. 9, 11 people who received these steroid injections had died of fungal meningitis, and 119 more had reportedly been sickened. Still more were anxiously waiting to see if they would develop symptoms of this non-contagious form of the disease.
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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.
Beach Boys Songs Written Decades Ago Triggered Current Quarrel With Lawyers
There's current litigation in the ongoing Beach Boys litigation saga. A lawsuit filed in 2019 against Nevada residents Mike Love and his wife Jacquelyne in the U.S. District Court for the District of Nevada that alleges inaccurate payment by the Loves under the retainer agreement and seeks $84.5 million in damages.
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.
When Is a Repair Structural or Nonstructural Under a Commercial Lease?
A common question that commercial landlords and tenants face is which of them is responsible for a repair to the subject premises. These disputes often center on whether the repair is "structural" or "nonstructural."