The regulation of biological products is conducted within the framework Title 21 of the US Code of Federal Regulations (CFR). These regulations describe product and clinical testing requirements for drugs and biological products, as well as the requirements for licensure of such products. The requirements outlined in the CFR also apply to combination vaccines. In addition, the Center for Biolog...

BACKGROUND In Australia there have been many calls for government action to halt the effects of unhealthy food marketing on children's health, yet implementation has not occurred. The attitudes of those involved in the policy-making process towards regulatory intervention governing unhealthy food marketing are not well understood. The objective of this research was to understand the perceptions...

This article discusses government regulation and the consequent compliance costs for the private sector from the perspective of transaction cost economics. In many cases, government regulation is shaped as legally binding standards. In order to comply with these standards, private sector firms meet various types of transaction costs, such as the bonding costs that the principal/agent relationsh...

1. INTRODUCTION Clinical trials have identified effective new cancer therapies and screening strategies. Additional clinical trials are needed for further progress in cancer prevention, screening, and treatment. However, clinical trials raise ethical concerns because volunteers take on risk for the primary goal of advancing scientific knowledge and helping future patients. Moreover, the risks a...

The 1940s were a decade of sharp contraction in wage inequality, particularly at the top of the distribution. We study this narrowing using a new dataset on the compensation of top executives. Relative to average earnings, median executive pay declined 0.34 log points from 1940 to 1949. We find that government regulation—including explicit salary restrictions and taxation—had, at best, a modest...

Ken Iverson, a technology entrepreneur, almost singlehandedly revived the moribund US steel industry. His success contains important lessons for health care. Nucor, the steel-focused factory Iverson managed, differed from the everything-for-everybody steel behemoths of yore, like Bethlehem Steel, with its specialty steel products and relatively small mini-mills, as did his egalitarian, producti...

The history of the mining industry is intimately connected with government regulation. As in many other countries, this reflects the fact that the Crown has reserved almost all mineral rights to itself. In many cases regulation has had adverse consequences for the sector. A notorious example was the ban on exports of iron ore in the 1960s, which depressed exploration activity and postponed the ...

The persistently high number of people reporting that they have no health insurance has precipitated a number of new comprehensive proposals to extend coverage to most Americans. Such proposals must find solutions to fundamental problems that have thus far eluded policymakers, including the role of government regulation, how much to spend, and who should pay. The experience of the 1990s suggest...

The paper tests the applicability of Whitley’ s business systems framework to the study of international differences in corporate ownership structure. In support of Whitley’ s framework we document the existence of large differences among the largest companies in 12 European nations. Furthermore we find that these differences can be partly attributed to the institutional determinants stressed b...

Antitrust litigation involving hospitals is common. This paper describes recent developments and underlying issues in antitrust law with respect to hospital-hospital relations, hospital-physician relations, and hospital-payer relations. A key unanswered question in each of these areas is how government regulation and public purchasing affect competitive markets for hospital services.