BACKGROUND The United States Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) consists of adverse event (AE) reports linked to approved drugs. The database is widely used to support post-marketing safety surveillance programs. Sometimes cited as a limitation to the usefulness of FAERS, however, is the 'Weber effect,' which is often summarized by stating that AE report...

Recent years have seen countries introducing reform of their utility industries with a view to promoting private ownership and competition. This paper studies the effect of the sequencing of privatisation, competition and regulation reforms in electricity generation using data from 25 developing countries for the period 1985 to 2001. A fixed effects panel data model is used. The study finds tha...

While the global and the Sri Lankan populations are still increasing those who require the whole range of infertility treatment is also on the rise. Ethical considerations in provision of infertility care have been a cause for concern from ancient times as to have a child, “even at any cost”, is a basic human biological need. With the availability of the higher levels of technology by way of As...

This paper documents the vulnerability of the UK workplace safety regime to ‘regulatory degradation’. Following a brief overview of this regime, the paper examines the dominant arguments within academic literature on appropriate and feasible regulatory enforcement, arguing that the approaches to regulation thereby advocated have been easily degraded as a result of their compatibility with neoli...

Many owners and operators of concentrated animal feeding operations (CAFO) need to secure National Pollutant Discharge Elimination System permits from the federal or state permitting authority. Because of the expense and inconvenience of permit applications, farm groups have challenged revisions to the federal CAFO Rule as well as state regulations claiming selected provisions exceeded the auth...

Why do countries differ so much in the extent to which they adopt neo-liberal, marketoriented reform in their infrastructure industries? Building on world-society and neo-institutional theories in sociology, we argue that international pressures of coercion, normative emulation, and competitive mimicry strongly influence the domestic adoption of market-oriented reform. We consider the effect of...

Preventing harm to the patient is the priority during a crisis. After a major incident, and especially when a patient has been harmed, there are a number of matters to be addressed: the ongoing care of the patient; documentation of the incident; investigation of the root causes; completion of reports; interviews with the patient and/or the next of kin, together with apologies and expression of ...

The physicians of today and tomorrow face the most daunting set of regulations ever imposed on the practice of medicine. Through the passage of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the federal government has thrust its regulatory authority into three of the most controversial and cutting-edge issues in medical practice management: privacy, electronic transact...

Background A growing number of drug development studies that include pharmacokinetic evaluations are conducted in regions lacking a specialised pharmacology laboratory. This necessitated the development of an International Pharmacology Specialty Laboratory (IPSL) in Zimbabwe. Objectives The aim of this article is to describe the development of an IPSL in Zimbabwe. Methods The IPSL was devel...

91 National Tax Journal Vol. LVl, No. 1, Part 1 March 2003 Abstract Concerns about devolving environmental regulatory powers to lower levels of government permeate debates in the U.S. and Europe about the appropriate level of regulatory authority. In theory, given a long list of conditions, regulatory competition by local governments can be efficient in the same way that tax competition can be ...