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News from the FDA
Pilot Programs for Fast-Track Drugs
Two related guidances for industry have just been published as part of a series of guidance documents that the FDA agreed to draft and implement in conjunction with the June 2002 reauthorization of the Prescription Drug User Fee Act of 1992 (PDUFA). The publications are: “Continuous Marketing Applications: Pilot 1 – Reviewable Units for Fast Track Products Under PDUFA” and “Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions During Development of Fast Track Products under the Prescription Drug User Fee Act of 1992.”
Under the CMA pilot program, Pilot 1, applicants submitting new drug applications or biological licensing applications for products that have been designated as Fast Track drug or biological products (ie, products intended to treat a serious and/or life-threatening disease for which there is an unmet medical need) may be eligible to submit portions of their marketing applications (reviewable units) in advance of the complete marketing application. The FDA has agreed to complete reviews of reviewable units within a specified time and to provide early feedback for those pre-submissions in the form of discipline review letters. Pilot 1 is an exploratory program that will allow the FDA to evaluate the added value, costs and impact of early review and feedback on parts of applications (reviewable units) in advance of submission of the complete application. For more information, go to:
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.