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News from the FDA
Collection of Race and Ethnicity Data
The FDA has published a draft Guidance for Industry to recommend categories for collecting effectiveness and safety data during clinical trials for ethnic and racial demographic groups.
FDA regulations require drug sponsors to present an analysis of data according to age, gender and race. An analysis of modifications of dose or dosage intervals for specific groups is also required when manufacturers submit a new drug application for approval by FDA. To accomplish this, the FDA recommends that the drug manufacturers use the Office of Management and Budget (OMB) race and ethnicity categories during clinical trial data collection to ensure consistency in evaluating potential differences in drug response among racial and ethnic groups.
Although the regulations governing medical devices do not include requirements for the collection of demographic data comparable to those for drugs, for those cases in which race and ethnicity data are necessary to determine the safety and effectiveness of a device, FDA encourages sponsors to collect the data in accordance with the OMB information collection standards discussed in this guidance document. Sponsors are also encouraged to discuss any race or ethnicity issue with the appropriate review division within the Office of Device Evaluation, Center for Devices and Radiological Health, when developing their study protocols.
An FDA Talk Paper on
the subjects can be found at: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01193.html.
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.
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.
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?