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https://www.readbyqxmd.com/read/27906534/food-and-drug-administration-review-and-action-on-over-the-counter-time-and-extent-applications-final-rule
#1
(no author information available yet)
The Food and Drug Administration (FDA or Agency) is amending its nonprescription (over-the-counter or OTC) drug regulations. This final rule supplements the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA's review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). It also amends the existing TEA process to include filing determination and withdrawal provisions to make the TEA process more efficient.
November 23, 2016: Federal Register
https://www.readbyqxmd.com/read/27906532/medical-gas-containers-and-closures-current-good-manufacturing-practice-requirements-final-rule
#2
(no author information available yet)
The Food and Drug Administration (FDA or the Agency) is amending its current good manufacturing practice (CGMP) and labeling regulations regarding medical gases. FDA is requiring that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. FDA is also requiring that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and color requirements...
November 18, 2016: Federal Register
https://www.readbyqxmd.com/read/27906504/combination-of-two-epitope-identification-techniques-enables-the-rational-design-of-soy-allergen-gly-m-4-mutants
#3
Heide Havenith, Karolin Kern, Paul Rautenberger, Holger Spiegel, Michael Szardenings, Elke Ueberham, Jörg Lehmann, Matthias Buntru, Simon Vogel, Regina Treudler, Rainer Fischer, Stefan Schillberg
BACKGROUND: Detailed IgE-binding epitope analysis is a key requirement for the understanding and development of diagnostic and therapeutic agents to address food allergies. METHODS: We combined an IgE-specific linear peptide microarray with random phage peptide display for the high-resolution mapping of IgE-binding epitopes of the major soybean allergen Gly m 4, which is a homologue to the birch pollen allergen Bet v1. RESULTS: Three epitopes were identified and mapped to a resolution of four key amino acids, allowing the rational design and the production of three Gly m 4 mutants with the aim to abolish or reduce the binding of epitope-specific IgE...
December 1, 2016: Biotechnology Journal
https://www.readbyqxmd.com/read/27906472/long-term-clinical-impact-and-cost-effectiveness-of-obeticholic-acid-for-the-treatment-of-primary-biliary-cholangitis
#4
Sumeyye Samur, Matthew Klebanoff, Reiner Banken, Daniel S Pratt, Rick Chapman, Daniel A Ollendorf, Anne M Loos, Kathleen Corey, Chin Hur, Jagpreet Chhatwal
: Primary biliary cholangitis (PBC) is a chronic, progressive autoimmune liver disease that mainly affects middle-aged women. Obeticholic acid (OCA), which was recently approved by the Food and Drug Administration for PBC treatment, has demonstrated positive effects on biochemical markers of liver function. Our objective was to evaluate the long-term clinical impact and cost-effectiveness of OCA as a second-line treatment for PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA...
November 7, 2016: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/27906463/measurement-of-behavioral-taste-responses-in-mice-two-bottle-preference-lickometer-and-conditioned-taste-aversion-tests
#5
Dany Gaillard, Jennifer M Stratford
The natural like and dislike of foods based on taste is one of the most easily observed behaviors in animals. Animals eat palatable foods and reject aversive foods, which makes measurement of taste perception possible using various behavioral techniques. Three different methods to accurately measure taste behavior are described here. First, two-bottle preference tests evaluate whether a taste compound (tastant) is preferred over water. Second, lickometer tests quantify the like and dislike for multiple concentrations of the same tastant or multiple tastants at the same time...
December 1, 2016: Current Protocols in Mouse Biology
https://www.readbyqxmd.com/read/27906456/environmental-risk-factors-for-diabetes-mellitus-in-cats
#6
M Öhlund, A Egenvall, T Fall, H Hansson-Hamlin, H Röcklinsberg, B S Holst
BACKGROUND: Diabetes in cats resembles type 2 diabetes in people. The etiology is not fully understood, but both genetic and environmental factors are believed to contribute. OBJECTIVES: To assess the associations of environmental risk factors with diabetes in cats. ANIMALS: Cats with a diagnosis of diabetes (n = 396) insured by a Swedish insurance company during years 2009-2013, and a control group (n = 1,670) matched on birth year. METHODS: A web-based questionnaire was used in a case-control study...
December 1, 2016: Journal of Veterinary Internal Medicine
https://www.readbyqxmd.com/read/27906146/peanut-skin-extract-mediated-synthesis-of-gold-nanoparticles-silver-nanoparticles-and-gold-silver-bionanocomposites-for-electrochemical-sudan-iv-sensing
#7
Alok Pani, Tran Duy Thanh, Nam Hoon Kim, Joong Hee Lee, Soon-Il Yun
Sustainable methods are needed for rapid and efficient detection of environmental and food pollutants. The Sudan group of dyes has been used extensively as adulterants in food and also are found to be polluting the soil and water bodies. There have been several methods for detection of Sudan dyes, but most of them are not practical enough for common use. In this study, the electrochemical detection efficiency and stability of gold nanoparticle (AuNPs), silver NPs and Au-Ag bionanocomposites, synthesised by peanut skin extract, modified glassy carbon electrode has been investigated...
December 2016: IET Nanobiotechnology
https://www.readbyqxmd.com/read/27906139/myxobacteria-mediated-synthesis-of-silver-nanoparticles-and-their-impregnation-in-wrapping-paper-used-for-enhancing-shelf-life-of-apples
#8
Swati Bhople, Swapnil Gaikwad, Swapna Deshmukh, Shital Bonde, Aniket Gade, Sanjib Sen, Anna Brezinska, Hanna Dahm, Mahendra Rai
The authors report Myxobacteria virescens (M. virescens) mediated synthesis of silver nanoparticles (AgNPs) and its efficacy against Staphylococcus aureus (ATCC-33591), Salmonella typhi (ATCC-51812), Escherichia coli (E. coli) (ATCC-14948), Klebsiella pneumoniae (MTCC-4030) and Pseudomonas aeruginosa (MTCC-4673). The organism exhibiting resistance to various antibiotics showed remarkable sensitivity, when used in combination of antibiotics and AgNPs. Antimicrobial property of AgNPs is playing a significant role in medicine and food storage...
December 2016: IET Nanobiotechnology
https://www.readbyqxmd.com/read/27906117/carotid-artery-stenting-versus-no-stenting-assisting-thrombectomy-for-acute-ischaemic-stroke-protocol-for-a-systematic-review-of-randomised-clinical-trials-with-meta-analyses-and-trial-sequential-analyses
#9
Henrik Steglich-Arnholm, Markus Holtmannspötter, Christian Gluud, Derk Wolfgang Krieger
BACKGROUND: In patients with intracranial large vessel arterial occlusion, ipsilateral extracranial carotid artery occlusions or near-occlusions pose a significant hurdle in endovascular management of acute ischaemic stroke. Stenting of the carotid lesion may be beneficial in this situation to provide a stable access for introducing catheters through the carotid lesion into the intracranial vasculature and the target occlusion. Furthermore, carotid stenting may ensure ample blood flow for wash-out of clot material and reperfusion of the ischaemic penumbral tissue...
December 1, 2016: Systematic Reviews
https://www.readbyqxmd.com/read/27906116/embracing-change-striated-for-smooth-muscle-replacement-in-esophagus-development
#10
REVIEW
Robert S Krauss, Daisuke Chihara, Anthony I Romer
The esophagus functions to transport food from the oropharyngeal region to the stomach via waves of peristalsis and transient relaxation of the lower esophageal sphincter. The gastrointestinal tract, including the esophagus, is ensheathed by the muscularis externa (ME). However, while the ME of the gastrointestinal tract distal to the esophagus is exclusively smooth muscle, the esophageal ME of many vertebrate species comprises a variable amount of striated muscle. The esophageal ME is initially composed only of smooth muscle, but its developmental maturation involves proximal-to-distal replacement of smooth muscle with striated muscle...
August 8, 2016: Skeletal Muscle
https://www.readbyqxmd.com/read/27906080/tonic-and-burst-spinal-cord-stimulation-waveforms-for-the-treatment-of-chronic-intractable-pain-study-protocol-for-a-randomized-controlled-trial
#11
Konstantin V Slavin, Richard B North, Timothy R Deer, Peter Staats, Kristina Davis, Roni Diaz
BACKGROUND: Burst stimulation is a novel form of neurostimulation for the treatment of chronic pain which has demonstrated promise in small uncontrolled studies, but has not yet gained approval for use in the U.S. We report the study methods for an ongoing multicenter, randomized, controlled, cross-over study designed to gain United States Food and Drug Administration (FDA) approval for burst stimulation. METHODS: Participants who are candidates for a currently approved neurostimulation device were enrolled and screened...
December 1, 2016: Trials
https://www.readbyqxmd.com/read/27906014/acceptability-and-use-of-ready-to-use-supplementary-food-compared-to-corn-soy-blend-as-a-targeted-ration-in-an-hiv-program-in-rural-haiti-a-qualitative-study
#12
Anne G Beckett, Debbie Humphries, J Gregory Jerome, Jessica E Teng, Patrick Ulysse, Louise C Ivers
BACKGROUND: Ready-to-use supplementary food (RUSF) is increasingly used as a component of food rations for adults with HIV. METHODS: We undertook a qualitative study to evaluate the acceptability and use of peanut-based RUSF compared to corn-soy blend (CSB) among adults living with HIV in rural Haiti who had been enrolled in a prospective, randomized trial comparing the impact of those rations. A total of 13 focus groups were conducted with 84 participants-42 selected from the RUSF arm of the study, and 42 from the CSB arm-using a guide with pre-designated core topics and open-ended questions...
February 17, 2016: AIDS Research and Therapy
https://www.readbyqxmd.com/read/27905961/estimating-average-alcohol-consumption-in-the-population-using-multiple-sources-the-case-of-spain
#13
Luis Sordo, Gregorio Barrio, María J Bravo, Joan R Villalbí, Albert Espelt, Montserrat Neira, Enrique Regidor
BACKGROUND: National estimates on per capita alcohol consumption are provided regularly by various sources and may have validity problems, so corrections are needed for monitoring and assessment purposes. Our objectives were to compare different alcohol availability estimates for Spain, to build the best estimate (actual consumption), characterize its time trend during 2001-2011, and quantify the extent to which other estimates (coverage) approximated actual consumption. METHODS: Estimates were: alcohol availability from the Spanish Tax Agency (Tax Agency availability), World Health Organization (WHO availability) and other international agencies, self-reported purchases from the Spanish Food Consumption Panel, and self-reported consumption from population surveys...
June 2, 2016: Population Health Metrics
https://www.readbyqxmd.com/read/27905952/mental-health-and-urban-living-in-sub-saharan-africa-major-depressive-episodes-among-the-urban-poor-in-ouagadougou-burkina-faso
#14
Géraldine Duthé, Clémentine Rossier, Doris Bonnet, Abdramane Bassiahi Soura, Jamaica Corker
BACKGROUND: In sub-Saharan African cities, the epidemiological transition has shifted a greater proportion of the burden of non-communicable diseases, including mental and behavioral disorder, to the adult population. The burden of major depressive disorder and its social risk factors in the urban sub-Saharan African population are not well understood and estimates vary widely. We conducted a study in Ouagadougou, Burkina Faso, in order to estimate the prevalence of major depressive episodes among adults in this urban setting...
May 5, 2016: Population Health Metrics
https://www.readbyqxmd.com/read/27905924/current-knowledge-and-perspectives-of-paenibacillus-a-review
#15
REVIEW
Elliot Nicholas Grady, Jacqueline MacDonald, Linda Liu, Alex Richman, Ze-Chun Yuan
Isolated from a wide range of sources, the genus Paenibacillus comprises bacterial species relevant to humans, animals, plants, and the environment. Many Paenibacillus species can promote crop growth directly via biological nitrogen fixation, phosphate solubilization, production of the phytohormone indole-3-acetic acid (IAA), and release of siderophores that enable iron acquisition. They can also offer protection against insect herbivores and phytopathogens, including bacteria, fungi, nematodes, and viruses...
December 1, 2016: Microbial Cell Factories
https://www.readbyqxmd.com/read/27905874/are-sexually-selected-traits-affected-by-a-poor-environment-early-in-life
#16
Regina Vega-Trejo, Michael D Jennions, Megan L Head
BACKGROUND: Challenging conditions experienced early in life, such as a restricted diet, can detrimentally affect key life-history traits. Individuals can reduce these costs by delaying their sexual maturation, albeit at the price of the later onset of breeding, to eventually reach the same adult size as individuals that grow up in a benevolent environment. Delayed maturation can, however, still lead to other detrimental morphological and physiological changes that become apparent later in adulthood (e...
December 1, 2016: BMC Evolutionary Biology
https://www.readbyqxmd.com/read/27905857/recent-development-in-sample-preparation-and-analytical-techniques-for-determination-of-quinolone-residues-in-food-products
#17
Zhichao Zhang, Hefa Cheng
Used heavily in food animal production, quinolones occur widely in food products of animal origin. Development of highly sensitive and selective analytical techniques for the detection of quinolone residues, often at trace levels, in food samples is necessary to ensure food safety and understand their public health risk. With complex matrices, food samples typically require a series of pretreatment steps, such as powdering, homogenization, deproteinization, and filtration. This review summarizes the recent advances in extraction, concentration, and detection techniques for quinolones in food product samples, and briefly compares the advantages and limitations of major techniques...
December 1, 2016: Critical Reviews in Analytical Chemistry
https://www.readbyqxmd.com/read/27905825/saliva-volatile-biomarkers-and-profiles
#18
Maciej Milanowski, Paweł Pomastowski, Tomasz Ligor, Bogusław Buszewski
Saliva is an aqueous fluid found in the oral cavity playing fundamental role in the preservation and maintenance of oral health. Apart from higher-molecular-weight constituents it contains volatile organic compounds (VOCs) that may origin from such sources as blood or be result of bacterial metabolism. They can also reach the oral fluid through dissolving of volatiles from breath and consumed foods. Some of them may serve as biomarkers of various diseases, such as dimethyl disulfide (halitosis), pyridine (periodontal disease) and trimethylamine (trimethylaminuria) or occupational exposure...
December 1, 2016: Critical Reviews in Analytical Chemistry
https://www.readbyqxmd.com/read/27905700/use-of-ozone-depleting-substances-direct-final-rule
#19
(no author information available yet)
The Food and Drug Administration (FDA, the Agency, or we) is amending its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as "essential uses" under the Clean Air Act. Essential-use products are exempt from the ban by FDA on the use of CFCs and other ODS propellants in FDA-regulated products and from the ban by the Environmental Protection Agency (EPA) on the use of ODSs in pressurized dispensers. The products that will no longer constitute an essential use are: Sterile aerosol talc administered intrapleurally by thoracoscopy for human use and metered-dose atropine sulfate aerosol human drugs administered by oral inhalation...
October 26, 2016: Federal Register
https://www.readbyqxmd.com/read/27905651/-current-evidence-on-health-benefits-of-the-mediterranean-diet
#20
Catalina Dussaillant, Guadalupe Echeverría, Inés Urquiaga, Nicolás Velasco, Attilio Rigotti
The Mediterranean diet is currently considered a functional diet with an increasing amount of scientific evidence that supports its beneficial effects in human health. Several observational cross-sectional and prospective cohort studies show an association between this diet and a lower prevalence and incidence of chronic diseases, such as cardiovascular disease, cancer, metabolic syndrome, diabetes, and neurodegenerative diseases as well as a reduced overall mortality. Additionally, clinical interventional studies, particularly the PREDIMED (Prevención con Dieta Mediterránea) initiative, have shown, with high quality scientific evidence, that a Mediterranean diet -supplemented either with olive oil or nuts- can lower by 30% the incidence of cardiovascular disease, reverse the metabolic syndrome, and prevent the development of diabetes and aging-related cognitive decline...
August 2016: Revista Médica de Chile
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