a 1993 executive order, similar to two Reagan orders that it replaced, requiring most proposed regulations to undergo economic and risk analyses. In 1996, the Office of Management and Budget issued more detailed guidelines on how to conduct those analyses, consistent with the Clinton order. Those measures would have provided an adequate basis for review of agency-proposed rules if the administr...

Drastic regulatory changes in Japan since 1997 have had a considerable impact on the way new medicines are developed. The regulatory authority itself has been transformed. Clinical trials are now performed according to international guidelines. Clinical data generated in one area are acceptable in the rest of the world in some cases through a bridging process that is viewed as only temporary. T...

background the unregulated availability and irrational use of tuberculosis (tb) medicines is a major issue of public health concern globally. governments of many low- and middle-income countries (lmics) have committed to regulating the quality and availability of tb medicines, but with variable success. regulation of tb medicines remains an intractable challenge in many settings, but the reason...

Prevention, control and eradication are three different goals or outcomes for dealing with avian influenza (AI) outbreaks in commercial poultry of the USA. These goals are achieved through various strategies developed using components of biosecurity (prevention or reduction in exposure), surveillance and diagnostics, elimination of infected poultry, decreasing host susceptibility to the virus (...

This paper considers a bi-level hazmat transportation network design problem in which hazmat shipments have to be transported over a road network between specified origin-destination points. The bi-level framework involves a regulatory authority and hazmat carriers. The control variables for the regulatory authority are locations of hazmat response teams and which additional links to include fo...

Delegation is a pervasive phenomenon in firms, procurement contracting, financial and regulatory institutions. Owners frequently delegate management of the firm to top level managers, who in turn delegate management of divisions to middle level managers. In procurement contracting, the purchaser often contracts with a single ‘prime’ contractor, delegating the responsibility of subcontracting wi...