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Lietzan E 《Journal of health law》2006,39(4):415-449
In approving the Food and Drug Administration's (FDA) Fiscal Year 2007 budget, the House approved an amendment that would prevent the agency from using appropriated funds to waive certain conflicts of interest identified by members of its advisory committees. The amendment, introduced by Representative Hinchey and known as the Hinchey Amendment, provides that no funds may be used to: waive a conflict of interest under Section 505(n)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA) for any voting member of an FDA advisory committee or panel; or make a certification under Section 208(b)(3) of Title 18 of the U.S. Code for any such voting member. This creates a problem, as ties to industry create the very expertise that FDA values in its outside advisors-under the Hinchey Amendment, these very ties would prevent them from serving as advisors to FDA during the drug approval process. The author opposes this change in the law and argues that the Hinchey Amendment would undermine congressional efforts in 1962 and 1989 to carefully balance the goals of attracting qualified experts and protecting agency decisionmaking. Further, the author argues, this change is unnecessary at FDA, because experts on FDA advisory committees divulge their connections to the industry, because the committees offer only advice and do not make agency decisions, and because the agency is under the watchful eye of Congress, the public, and public interest groups. The Article concludes that although FDA's advisory committee conflict-of-interest process can be improved, congressional action is unnecessary, and a change in the law through amendment to an appropriations bill that does not go through the ordinary legislative process (as an amendment to the FDCA or Title 18 would) is inappropriate. Instead, recommendations from organizations studying FDA practice, such as the OIG, GAO, and IOM, should be used to carefully and reflectively amend the process at the agency level, within the existing statutory framework. 相似文献
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Bernal LP Borjas L Zabala W Portillo MG Fernández E Delgado W Tovar F Lander N Chiurillo MA Ramírez JL García O 《Forensic science international》2006,161(1):60-63
Allele frequencies for 15 short tandem repeats (STRs) autosomal loci (D8S1179, D21S11, D7S820, CSF1PO, D3S1358, TH01, D13S317, D16S539, D2S1338, D19S433, vWA, TPOX, D18S51, D5S818 and FGA, included in the AmpFLSTR Identifiler, Applied Biosystems) were studied in the city of Maracaibo, Venezuela and were compared with other published Latin-American populations for the same loci. Population and forensic parameters were estimated. 相似文献
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Erika J. van Elsas Armen Hakhverdian Wouter van der Brug 《West European politics》2016,39(6):1181-1204
In Western European democracies opposition to the European Union is commonly found at the ideological extremes. Yet, the Euroscepticism of radical left-wing and radical right-wing parties has been shown to have distinct roots and manifestations. The article investigates whether these differences are mirrored at the citizen level. Using data from the European Election Study (2009/2014) and the European Social Survey (2008/2012) in 15 West European countries, it is found that left-wing and right-wing citizens not only differ in the object of their Euroscepticism, but also in their motivations for being sceptical of the EU. Left-wing Eurosceptics are dissatisfied with the current functioning of the EU, but do not oppose further European integration per se, while right-wing Eurosceptics categorically reject European integration. Euroscepticism among left-wing citizens is motivated by economic and cultural concerns, whereas for right-wing citizens Euroscepticism is solely anchored in cultural attitudes. These results refine the common ‘horseshoe’ understanding of ideology and Euroscepticism. 相似文献
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The principle of subsidiarity, one of the most important in European Union (EU) law and entrenched in the EU treaties, has recently entered the constitutional discourse in Canada thanks to some Supreme Court decisions regarding division of powers. After a brief overview of the intellectual history of subsidiarity, this article offers a comparison of how subsidiarity has been dealt with by the Supreme Court of Canada and by the European Court of Justice. The ultimate goal is to see what lessons Canada can draw from the EU's longstanding experience with subsidiarity, particularly in the ambit of social policy. 相似文献
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While substantial research examines the dynamics prompting policy adoption, few studies have assessed whether enacted policies are modified to meet distributional equity concerns. Past research suggests that important forces limit such adaptation, termed here "policy inertia." We examine whether block grant allocations to states from the Ryan White HIV/AIDS Program have evolved in response to major technological and political changes. We assess the impact of initial allocations on later funding patterns, compared to five counterfactual distributional equity standards. Initial allocations strongly predict future allocations; in comparison, the standards are weak predictors, suggesting the importance of policy inertia. Our methodology of employing multiple measures of equity as a counterfactual to policy inertia can be used to evaluate the adaptability of federalist programs in other domains. 相似文献
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James D Sidaway Jennie Walmsley Mohamed M El‐Doufani Erika G Alin Camillia Fawzi El‐Solh John Harriss 《Third world quarterly》2013,34(3):567-568
Mozambique: who calls the shots. by Joseph Hanlon, London: James Currey. 1991. 301pp. £11.95pb Renamo: terrorism in Mozambique. by Alex Vines, London: James Currey. 1991. 176pp. £7.95pb Behind the Intifada: labor and women's movements in the occupied territories. by Joost R Hiltermann, Princeton, New Jersey: Princeton University Press. 265pp Original Sins: Reflections on the History of Zionism and Israel. by Benjamin Beit‐Hallahmi, London and Concord: Pluto Press 1992, 218pp Living Together Separately: Arabs and Jews in Contemporary Jerusalem. by Michael Romann and Alex Weingrod, Princeton: Princeton University Press. 1991. 258pp Veiled Half‐Truths: Western Travellers’ Perceptions of Middle Eastern Women. by Judy Mabro, London: IB Tauris. 1991 Ethnicity and Nationalism: theory and comparison. by Paul R Brass, New Delhi/Newbury Park/London: Sage Publications. 1991. 358pp Policy Options for the Singapore Economy. by Lim, Chong‐Yah and Associates, London and Singapore: McGraw‐Hill. 1988. 499pp $US42.50 hb Management of Success: The Moulding of Modern Singapore. edited by K S Sandhu and Paul Wheatley, Singapore: Institute of Southeast Asian Studies. 1989. 1134 pp $US89. hb and $US59.90 sb. Ethiopia: Transition and Development in the Horn of Africa. by Mulatu Wubneh and Yohannis Abate, Boulder, Colorado: Westview Press, 1988. 224pp. £32 Storm Signals: Structural Adjustment and Development Alternatives in the Caribbean. by Kathy McAfee, London: Zed Books. 1991. The Significance of the Commonwealth 1965–90. by W David McIntyre London: Macmillan (Cambridge Commonwealth Series). 1991. 305pp Multiple‐Shift Schooling: Design and Operation for Cost‐Effectiveness. by Mark Bray London: Commonwealth Secretariat. 1989. 155pp. £4.00pb 相似文献