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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.
Compounding Through the Years
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Yachts, Jets, Horses & Hooch: Specialized Commercial Leasing Models
Defining commercial real estate asset class is essentially a property explaining how it identifies — not necessarily what its original intention was or what others think it ought to be. This article discusses, from a general issue-spot and contextual analysis perspective, how lawyers ought to think about specialized leasing formats and the regulatory backdrops that may inform what the documentation needs to contain for compliance purposes.
Hyperlinked Documents: The Latest e-Discovery Challenge
As courts and discovery experts debate whether hyperlinked content should be treated the same as traditional attachments, legal practitioners are grappling with the technical and legal complexities of collecting, analyzing and reviewing these documents in real-world cases.
Identifying Your Practice's Differentiator
How to Convey Your Merits In a Way That Earns Trust, Clients and Distinctions Just as no two individuals have the exact same face, no two lawyers practice in their respective fields or serve clients in the exact same way. Think of this as a "Unique Value Proposition." Internal consideration about what you uniquely bring to your clients, colleagues, firm and industry can provide untold benefits for your law practice.
Risks and Ad Fraud Protection In Digital Advertising
The ever-evolving digital marketing landscape, coupled with the industry-wide adoption of programmatic advertising, poses a significant threat to the effectiveness and integrity of digital advertising campaigns. This article explores various risks to digital advertising from pixel stuffing and ad stacking to domain spoofing and bots. It will also explore what should be done to ensure ad fraud protection and improve effectiveness.
Turning Business Development Plans Into Reality
This article offers practical insights and best practices to navigate the path from roadmap to rainmaking, ensuring your business development efforts are not just sporadic bursts of activity, but an integrated part of your daily success.