Professor Charlton Copeland offers a wide-ranging, ambitious critique of what he characterizes as federalism jurisprudence’s dominant models of “separation” and “allocation” of authority between the respective federal and state spheres. Judicial resolution of federalism questions, he suggests, turns inappropriately and incompletely on the moment of a law’s enactment. This “obsession with the le...

Essential Documents also serve a number of other important purposes. Filing essential documents at the investigator/institution and sponsor sites in a timely manner can greatly assist in the successful management of a trial by the investigator, sponsor, and monitor. These documents are also the ones that are usually audited by the sponsor's independent audit function and inspected by the regula...

The UK Financial Services Authority (FSA) leads the way in the development of Principles-based regulation of the financial services industry. It is proposing a significant shift towards reliance on broadly stated Principles rather than more detailed rules. The implications of a more Principles-based approach for regulators, those regulated by the FSA and those whose interests the regulatory reg...

Scholars of differing political affiliation and the President's Council on Bioethics have called for regulation of assisted reproductive technology (ART) that would emulate many aspects of the regulatory system of the United Kingdom, in particular that of the Human Fertilisation and Embryology Authority. Specifically, scholars and the Council have argued that research in the U.S. involving game...

General information and drug reimbursement in the study countries, 2003 This study forms part of the IRDES programme of research on pharmaceutical policy, and compares the regulatory framework and contents of baskets of reimbursed drugs in three European countries: France, Germany and England. It is a contribution to the current debate on reimbursement of drugs of insufficient therapeutic value...

Current System of Care Emergency Medical Services System Design Prehospital EMS systems have 3 major components: emergency medical dispatch, public safety (fire and law enforcement) first response, and EMS ambulance response. Each of these operates within a broader emergency care system, which includes acute care facilities and regionalized healthcare services. In most states, an EMS regulatory...

New Authority Over Radioisotopes One set of regulations delegates new authority over radioisotopes to the Nuclear Regulatory Commission (NRC) and is a direct result of testimony submitted by NRC officials to the U.S. House of Representatives Subcommittee on National Security, Emerging Threats, and International Relations and to the U.S. Senate in 2004. In addition to enhanced security measures ...

When it comes to consumer protection in the building industry, it is fair to say that the local government authority building inspector I has never been seen as being in the front line of the maintenance or improvement of building standards. Theirs is the secondary role of supervising others in an attempt to keep them honest. Even so, there is room for difference of opinion as to the nature of ...

impose any additional regulatory requirements on sources beyond those imposed by state law. A redesignation to attainment does not in and of itself create any new requirements, but rather results in the applicability of requirements contained in the CAA for areas that have been redesignated to attainment. Moreover, the Administrator is required to approve a SIP submission that complies with the...