Law Commons^™

Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget

Seattle University Law Review

Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …

Slides: Best Management Practices For Oil And Gas Development And Comparative Water Quality Database Of Regulations Relating To Shale Oil And Gas, Matt Samelson, University Of Colorado Boulder. Getches-Wilkinson Center For Natural Resources, Energy, And The Environment. Intermountain Oil And Gas Bmp Project

Fracking, Water Quality and Public Health: Examining Current Laws and Regulations (March 20)

Presenter: Matt Samelson, J.D., Attorney, Consultant for Intermountain Oil and Gas Best Management Practices (BMP) Project, Getches-Wilkinson Center for Natural Resources, Energy and the Environment, University of Colorado Law School

34 slides

Speaking Of Science: Introducing Notice And Comment Into The Legislative Process, Gregory Dolin

All Faculty Scholarship

Congress enacts, on a nearly continuous basis, a variety of laws that affect scientific research and progress. Some of these laws have an unquestionably positive effect. For instance, Congress's creation of the National Institutes of Health, the National Academy of Sciences, and NASA; its various appropriations to fund ground-breaking research; and a multitude of other laws have incalculably advanced human knowledge, and it is to Congress's great credit that these laws have been and are continuing to be enacted. However, not all laws that affect the progress of sciences are an unalloyed good. Quite the opposite, often the laws aim …

Keep Your Eyes On Eyes In The Sky, Hillary B. Farber

Faculty Publications

To date, eight states have passed bills regulating domestic drone use by government and private individuals. This leaves us with a question: If a city of more than 60,000 residents and a global company with a customer base in the hundreds of millions are racing to the sky, how are we as a commonwealth of 6.6 million to truly launch ourselves into the debate and protect what little privacy we have left?

Copyright’S Private Ordering And The 'Next Great Copyright Act', Jennifer E. Rothman

All Faculty Scholarship

Private ordering plays a significant role in the application of intellectual property laws, especially in the context of copyright law. In this Article, I highlight some of the dominant modes of private ordering and consider what formal copyright law should do, if anything, to engage with private ordering in the copyright space. I conclude that there is not one single approach that copyright law should take with regard to private ordering, but instead several different approaches. In some instances, the best option is for the law to get out of the way and simply continue to provide room for various …