940 resultados para United States. Food and Drug Administration


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This paper summarizes current information on the American shad, Alosa sapidissima, and describes the species and its fishery. Emphasis is placed on (1) life history of the fish, (2) condition of the fishery by State and water areas in 1960 compared to 1896 when the last comprehensive description was made, (3) factors responsible for decline in abundance, and (4) management measures. The shad fishery has changed little over the past three-quarters of a century, except in magnitude of yield. Types of shad-fishing gear have remained relatively unchanged, but many improvements have been made in fishing techniques, mostly to achieve economy. In 1896 the estimated catch was more than 50 million pounds. New Jersey ranked first in production with about 14 million pounds, and Virginia second with 11 million pounds. In 1960 the estimated catch was slightly more than 8 million pounds. Maryland ranked first in production with slightly more than 1.5 million pounds, Virginia second with slightly less than 1.4 million pounds, and North Carolina third with about 1.3 million pounds. Biological and economic factors blamed for the decline in shad abundance, such as physical changes in the environment, construction of dams, pollution, over-fishing, and natural cycles of abundance, are discussed. Also discussed are methods used for the rehabilitation and management of the fishery, such as artificial propagation, installation of fish-passage facilities at impoundments, and fishing regulations. With our present knowledge, we can manage individual shad populations; but, we probably cannot restore the shad to its former peak of abundance.

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Diabetes mellitus is becoming increasingly prevalent worldwide. Additionally, there is an increasing number of patients receiving implantable devices such as glucose sensors and orthopedic implants. Thus, it is likely that the number of diabetic patients receiving these devices will also increase. Even though implantable medical devices are considered biocompatible by the Food and Drug Administration, the adverse tissue healing that occurs adjacent to these foreign objects is a leading cause of their failure. This foreign body response leads to fibrosis, encapsulation of the device, and a reduction or cessation of device performance. A second adverse event is microbial infection of implanted devices, which can lead to persistent local and systemic infections and also exacerbates the fibrotic response. Nearly half of all nosocomial infections are associated with the presence of an indwelling medical device. Events associated with both the foreign body response and implant infection can necessitate device removal and may lead to amputation, which is associated with significant morbidity and cost. Diabetes mellitus is generally indicated as a risk factor for the infection of a variety of implants such as prosthetic joints, pacemakers, implantable cardioverter defibrillators, penile implants, and urinary catheters. Implant infection rates in diabetic patients vary depending upon the implant and the microorganism, however, for example, diabetes was found to be a significant variable associated with a nearly 7.2% infection rate for implantable cardioverter defibrillators by the microorganism Candida albicans. While research has elucidated many of the altered mechanisms of diabetic cutaneous wound healing, the internal healing adjacent to indwelling medical devices in a diabetic model has rarely been studied. Understanding this healing process is crucial to facilitating improved device design. The purpose of this article is to summarize the physiologic factors that influence wound healing and infection in diabetic patients, to review research concerning diabetes and biomedical implants and device infection, and to critically analyze which diabetic animal model might be advantageous for assessing internal healing adjacent to implanted devices.

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OBJECTIVES: To estimate the cause-specific prevalence and distribution of blindness and low vision in the United States by age, race/ethnicity, and gender, and to estimate the change in these prevalence figures over the next 20 years. METHODS: Summary prevalence estimates of blindness (both according to the US definition of < or =6/60 [< or =20/200] best-corrected visual acuity in the better-seeing eye and the World Health Organization standard of < 6/120 [< 20/400]) and low vision (< 6/12 [< 20/40] best-corrected vision in the better-seeing eye) were prepared separately for black, Hispanic, and white persons in 5-year age intervals starting at 40 years. The estimated prevalences were based on recent population-based studies in the United States, Australia, and Europe. These estimates were applied to 2000 US Census data, and to projected US population figures for 2020, to estimate the number of Americans with visual impairment. Cause-specific prevalences of blindness and low vision were also estimated for the different racial/ethnic groups. RESULTS: Based on demographics from the 2000 US Census, an estimated 937 000 (0.78%) Americans older than 40 years were blind (US definition). An additional 2.4 million Americans (1.98%) had low vision. The leading cause of blindness among white persons was age-related macular degeneration (54.4% of the cases), while among black persons, cataract and glaucoma accounted for more than 60% of blindness. Cataract was the leading cause of low vision, responsible for approximately 50% of bilateral vision worse than 6/12 (20/40) among white, black, and Hispanic persons. The number of blind persons in the US is projected to increase by 70% to 1.6 million by 2020, with a similar rise projected for low vision. CONCLUSIONS: Blindness or low vision affects approximately 1 in 28 Americans older than 40 years. The specific causes of visual impairment, and especially blindness, vary greatly by race/ethnicity. The prevalence of visual disabilities will increase markedly during the next 20 years, owing largely to the aging of the US population.

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13th Congress, 3d session. House. Doc. no. 13. October 28, 1814. Read, referred to the Committee on Foreign Relations. Printed by A. and G. Way

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En janvier 2008, une éclosion de réactions anaphylactoïdes (RA) potentiellement mortelles associées à l’injection intraveineuse d’héparine manufacturées en Chine et contaminée par le chondroïtine sulfate hypersulfaté (CSHS) a forcé le rappel de ces dernières par la U.S. Food and Drug Administration. Ces RA ont rapidement été attribuées à la libération de la bradykinine (BK) suite à l’activation du système de contact par le CSHS. Cependant, aucune évidence expérimentale définitive n’est à ce jour venue appuyer directement cette hypothèse. En se basant sur le nombre de morts déclaré et associé à la contamination (>150 morts au niveau mondial) ainsi qu’aux données épidémiologiques, qui stipulent que 25% des patients ayant développés une RA aux États-Unis étaient essentiellement des insuffisant rénaux en dialyse traités au moyen d’un inhibiteur de l’enzyme de conversion de l’angiotensine (iECA), nous avons émis l’hypothèse suivante : les RA causées par l’injection intraveineuse d’héparine contaminée au CSHS sont de nature multifactorielle et complexe. Le but de notre travail est donc, dans un premier temps, d’évaluer le pouvoir kininoformateur du CSHS en présence d’un iECA et de le comparer à celui du sulfate de dextran, un activateur de référence du système de contact. Comme les RA associées à l’injection intraveineuse d’héparine contaminée par le CSHS se produisent généralement dans les premières minutes des séances de dialyse, nous allons étudier l’effet de la dilution du plasma sur la quantité de BK libérée en présence ou en absence d’un iECA. Nous allons également mesurer les profils cinétiques de la libération de la BK sur un plasma stimulé par différents lots d’héparine contaminée, et associée à des RA, et nous comparerons cette cinétique avec celles d’une héparine de référence complémentée ou non avec différentes concentrations de CSHS synthétique. Enfin, nous allons caractériser le profil de libération de la BK et de son métabolite actif, la des-Arg9-BK, dans le plasma de patients dialysé ayant présenté une RA associée à une membrane de dialyse chargée négativement. L’application de méthodes expérimentales développées dans notre laboratoire nous a permis de montrer, pour la première fois, que l’héparine contaminée au CSHS a la capacité de libérer la BK à des concentrations susceptibles d’expliquer le rôle de ce peptide inflammatoire dans la physiopathologie des RA causées par l’injection intraveineuse d’héparine d’origine chinoise contaminée au CSHS.

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La incidencia de la tosferina ha mostrado un incremento en los últimos años; afectando predominantemente a los niños menores de 1 año, adolescentes y adultos. En el 2005 el Comité Asesor de Prácticas en Inmunización (ACIP) recomendó administrar una dosis de refuerzo de la vacuna acelular antipertussis a los adolescentes. Esta estrategia ha sido adoptada por distintos países. Sin embargo hasta el momento no existe una revisión sistemática que evalúe la efectividad de esta medida de prevención primaria. Métodos: Revisión sistemática de la literatura de artículos acerca de la efectividad de la vacuna acelular antipertussis como dosis de refuerzo en adolescentes. Resultados: La búsqueda inicial arrojó un total de 121 resultados, de los cuales solo 4 cumplieron los criterios de selección. Se evaluó en éstos, la inmunogenicidad generada contra tétanos y difteria por la vacuna Tdap vs Td con resultados significativos y similares. Además se documentó la respuesta inmunológica protectora generada por la Tdap contra tosferina. En cuanto a la reactogenicidad, en general fue baja. Discusión: La vacuna Tdap genera inmunogenicidad similar a la Td contra tétanos y difteria. Además proporciona adecuada protección contra la tosferina como dosis de refuerzo en los adolescentes. Conclusión: La evidencia disponible sugiere que se puede recomendar la vacuna Tdap como dosis de refuerzo en adolescentes entre los 10 y los 18 años de edad por su baja reactogenicidad y adecuada inmunogenicidad contra tétanos, difteria y B. Pertussis.

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The member countries of the World Health Organization have endorsed its Global Strategy on Diet, Physical Activity, and Health. We assess the potential consumption impacts of these norms in the United States, France, and the United Kingdom using a mathematical programming approach. We find that adherence would involve large reductions in the consumption of fats and oils accompanying large rises in the consumption of fruits, vegetables, and cereal. Further, in the United Kingdom and the United States, but not France, sugar intakes would have to shrink considerably. Focusing on sub-populations within each country, we find that the least educated, not necessarily the poorest, would have to bear the highest burden of adjustment.

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Foreword by Alicia Bárcena

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Document prepared on the occasion of the visit of President Barack Obama to Brazil, Chile and El Salvador in March 2011

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Erythrosine (ErB) is a xanthene and an US Food and Drug Administration approved dye used in foods, drugs and cosmetics. Although its utilization is permitted, ErB is described as inhibitor of enzymes and protein-protein interactions and is toxic to pituitary and spermatogenesis processes. However, the genotoxicity and mutagenicity of ErB is inconclusive in the literature. This study aimed to analyze the genotoxicity of this dye using the alkaline comet assay and is the first investigation to evaluate ErB mutagenicity using the cytokinesis block micronucleus cytome (CBMN-Cyt) assay in HepG2 cells. These cells were chosen because they produce phase I and phase II enzymes that can mimic in vivo metabolism. The cells were treated with seven concentrations (0.1-70.0 mu g mL(-1)) of ErB, and the results showed genotoxicity at the two highest concentrations and mutagenicity at six concentrations. Furthermore, as micronuclei result from clastogenic and aneugenic processes, while comet assay is often considered more sensitive and detects DNA single strain breaks, we suggest that an aneugenic is responsible for the observed damage. Although ErB is approved for use in the food, cosmetic and pharmaceutical industries, it must be used carefully because it damages the DNA structure. (C) 2012 Elsevier Ltd. All rights reserved.

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Le profonde trasformazioni che hanno interessato l’industria alimentare, unitamente alle accresciute capacità delle scienze mediche ed epidemiologiche di individuare nessi causali tra il consumo di determinate sostanze e l’insorgere di patologie, hanno imposto al legislatore di intervenire nella materia della c.d. sicurezza alimentare mettendo in atto sistemi articolati e complessi tesi a tutelare la salute dei consociati. Quest’ultimo obiettivo viene perseguito, da un lato, mediante disposizioni di natura pubblicistica e di carattere preventivo e, dall’altro lato, dallo strumento della responsabilità civile. Le due prospettive di tutela della salute delle persone costituiscono parti distinte ma al tempo stesso fortemente integrate in una logica unitaria. Questa prospettiva emerge chiaramente nel sistema statunitense: in quel ordinamento la disciplina pubblicistica della sicurezza degli alimenti – definita dalla Food and Drug Administration – costituisce un punto di riferimento imprescindibile anche quando si tratta di stabilire se un prodotto alimentare è difettoso e se, di conseguenza, il produttore è chiamato a risarcire i danni che scaturiscono dal suo utilizzo. L’efficace sinergia che si instaura tra la dimensione pubblicistica del c.d. Public Enforcement e quella risarcitoria (Private Enforcement) viene ulteriormente valorizzata dalla presenza di efficaci strumenti di tutela collettiva tra i quali la class action assume una importanza fondamentale. Proprio muovendo dall’analisi del sistema statunitense, l’indagine si appunta in un primo momento sull’individuazione delle lacune e delle criticità che caratterizzano il sistema nazionale e, più in generale quello comunitario. In un secondo momento l’attenzione si focalizza sull’individuazione di soluzioni interpretative e de iure condendo che, anche ispirandosi agli strumenti di tutela propri del diritto statunitense, contribuiscano a rendere maggiormente efficace la sinergia tra regole preventive sulla sicurezza alimentare e regole risarcitorie in materia di responsabilità del produttore.

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Whether the two drug-eluting stents approved by the US Food and Drug Administration-a sirolimus-eluting stent and a paclitaxel-eluting stent-are associated with increased risks of death, myocardial infarction, or stent thrombosis compared with bare-metal stents is uncertain. Our aim was to compare the safety and effectiveness of these stents.