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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:
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.
Removing Restrictive Covenants In New York
In Rockwell v. Despart, the New York Supreme Court, Third Department, recently revisited a recurring question: When may a landowner seek judicial removal of a covenant restricting use of her land?
"Holy Fair Use, Batman": Copyright, Fair Use and the Dark Knight
The copyright for the original versions of Winnie the Pooh and Mickey Mouse have expired. Now, members of the public can create — and are busy creating — their own works based on these beloved characters. Suppose, though, we want to tell stories using Batman for which the copyright does not expire until 2035. We'll review five hypothetical works inspired by the original Batman comic and analyze them under fair use.