Forward for two review articles authored by ISCT's North American Legal & Regulatory Affairs Committee on the regulatory framework for cellular & gene therapy product approval in the U.S. and Canada

Cytotherapy ◽  
2019 ◽  
Vol 21 (7) ◽  
pp. 685
Author(s):  
Donald G. Phinney
2019 ◽  
Vol 3 (3) ◽  
Author(s):  
Asa McKercher

Too Close for Comfort: Canada, the U.S. Civil Rights Movement, and the North American Colo(u)r Line


MRS Advances ◽  
2019 ◽  
Vol 4 (17-18) ◽  
pp. 987-992
Author(s):  
François Diaz-Maurin ◽  
Rodney C. Ewing

ABSTRACTThe “safety case” approach has been developed to address the issue of evaluating the performance of a geologic repository in the face of the large uncertainty that results for evaluations that extend over hundreds of thousands of years. This paper reviews the concept of the safety case as it has been defined by the international community. We contrast the safety case approach with that presently used in the U.S. repository program. Especially, we focus on the role of uncertainty quantification. There are inconsistencies between the initial proposal to dealing with uncertainties in a safety case and current U.S. practice. The paper seeks to better define the safety case concept so that it can be usefully applied to the regulatory framework of the U.S. repository program.


Author(s):  
Laura Padilla-Gonzalez ◽  
Amy Scott Metcalfe ◽  
Jesús F. Galaz-Fontes ◽  
Donald Fisher ◽  
Iain Snee

2007 ◽  
Vol 39 (1) ◽  
pp. 121-134 ◽  
Author(s):  
Dwi Susanto ◽  
C. Parr Rosson ◽  
Flynn J. Adcock

This paper examines the effect of the U.S.-Mexico trade agreement under the North American Free Trade Agreement (NAFTA). The results suggest that U.S. agricultural imports from Mexico have been responsive to tariff rate reductions applied to Mexican products. A one percentage point decrease in tariff rates is associated with an increase in U.S. agricultural imports from Mexico by 5.31% in the first 6 years of NAFTA and by 2.62% in the last 6 years of NAFTA. U.S. imports from Mexico have also been attributable to the pre-NAFTA tariff rates. Overall, the results indicate that the U.S-Mexico trade agreement under NAFTA has been trade creating rather than trade diverting.


Author(s):  
Richard D. Mahoney

How did the U.S.-Colombia free trade agreement come about? The officially named “U.S.-Colombia Trade Promotion Agreement” was the stepchild of a rancorous hemispheric divorce between the United States and five Latin American governments over the proposal to extend the North American Free Trade Agreement...


Author(s):  
Alan N. Rechtschaffen

This chapter discusses the origins of the 2007 financial crisis, subprime lending, and government-sponsored entities. It argues that the events driving financial markets to the precipice of collapse during the global financial meltdown gave rise to a regulatory framework that may have been a rational response to a market in free fall, but need to be reassessed in an era of recovery. In 2018, the U.S. economy may be, by many measures, viewed as wholly recovered from the economic impact of the crisis. The stock market is trading at record highs, having erased all the losses of the crisis period and then some. With this recovery, the Trump administration seeks to restrain the regulatory burden imposed during the crisis.


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