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The FDA's New Guidance on Data Integrity
The Food and Drug Administration (FDA) recently released a draft guidance for industry, “Data Integrity and Compliance with CGMP” (Current Good Manufacturing Practices). See http://1.usa.gov/25IzpM4. While the draft is not legally binding on industry or the agency, it offers the FDA's current thinking on how drug and biologic manufacturers can comply with current Good Manufacturing Practices, to ensure completeness, consistency, and accuracy of data. In recent years, FDA has taken numerous enforcement actions against companies for data integrity-related violations during GMP inspections. In addition to describing the agency's expectations, the document also offers companies a means to reduce potential product liability exposure.
This article highlights some of the key points in the guidance and attempts to identify the agency's central concerns and recommendations.
Key Definitions
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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.