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https://www.readbyqxmd.com/read/28439847/the-role-of-the-fda-and-regulatory-approval-of-new-devices-for-diabetes-care
#1
REVIEW
Shelley A Jazowski, Aaron N Winn
PURPOSE OF REVIEW: The Food and Drug Administration (FDA) is responsible for assuring the safety, effectiveness, and quality of medical devices in the USA. Extensive review times coupled with the demand for necessary treatments have prompted the policymakers to implement measures to speed medical devices to market.The purpose of this review is to summarize the evolution of the regulatory pathways through which medical devices utilized in diabetes care gain market access. RECENT FINDINGS: Regulatory pathways, ranging from premarket notification to premarket approval, require distinct, yet necessary ("least burdensome") evidence demonstrating a device's safety and effectiveness...
June 2017: Current Diabetes Reports
https://www.readbyqxmd.com/read/28438889/fda-approval-summary-nivolumab-for-the-treatment-of-relapsed-or-progressive-classical-hodgkin-lymphoma
#2
Yvette L Kasamon, R Angelo de Claro, Yaping Wang, Yuan Li Shen, Ann T Farrell, Richard Pazdur
On May 17, 2016, after an expedited priority review, the U.S. Food and Drug Administration granted accelerated approval to nivolumab for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin (BV). Nivolumab in cHL had been granted breakthrough therapy designation. Accelerated approval was based on two single-arm, multicenter trials in adults with cHL. In 95 patients with relapsed or progressive cHL after autologous HSCT and post-transplantation BV, nivolumab, dosed at 3 mg/kg intravenously every 2 weeks, produced a 65% (95% confidence interval: 55%-75%) objective response rate (58% partial remission, 7% complete remission)...
April 24, 2017: Oncologist
https://www.readbyqxmd.com/read/28438819/essentials-of-essential-oils
#3
Chelsea R Manion, Rebecca M Widder
PURPOSE: Information to guide clinicians in educating and advising patients using or intending to use essential oils for self-administered aromatherapy or other medicinal purposes is presented. SUMMARY: The term essential oils refers to highly concentrated, aromatic oils extracted from plants by steam distillation, hydrodiffusion, or pressure. Market reports indicate strong growth in the use of essential oils in the United States in recent decades. Therapeutic claims made in the marketing of essential oils have led the Food and Drug Administration to caution a number of suppliers...
May 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28437165/survey-for-listeria-monocytogenes-in-and-on-ready-to-eat-foods-from-retail-establishments-in-the-united-states-2010-through-2013-assessing-potential-changes-of-pathogen-prevalence-and-levels-in-a-decade
#4
John B Luchansky, Yuhuan Chen, Anna C S Porto-Fett, Régis Pouillot, Bradley A Shoyer, Rachel Johnson-DeRycke, Denise R Eblen, Karin Hoelzer, William K Shaw, Jane M van Doren, Michelle Catlin, Jeehyun Lee, Rohan Tikekar, Daniel Gallagher, James A Lindsay, Sherri Dennis
A multiyear interagency Listeria monocytogenes Market Basket Survey was undertaken for selected refrigerated ready-to-eat foods purchased at retail in four FoodNet sites in the United States. Food samples from 16 food categories in six broad groups (seafood, produce, dairy, meat, eggs, and combination foods) were collected weekly at large national chain supermarkets and independent grocery stores in California, Maryland, Connecticut, and Georgia for 100 weeks between December 2010 and March 2013. Of the 27,389 total samples, 116 samples tested positive by the BAX PCR system for L...
April 24, 2017: Journal of Food Protection
https://www.readbyqxmd.com/read/28436004/engineering-of-an-h2-o2-auto-scavenging-in-vivo-cascade-for-pinoresinol-production
#5
Yongkun Lv, Xiaozhong Cheng, Guocheng Du, Jingwen Zhou, Jian Chen
Pinoresinol is a natural lignan with a high market value that has potential pharmacological and food supplement applications. Pinoresinol is currently isolated from plants, which suffers from low efficiency and yield. To produce pinoresinol from inexpensive and industrially available eugenol, an in vivo enzymatic cascade composed of vanillyl alcohol oxidase and peroxidase was designed, which scavenges H2 O2 automatically and eliminates protein purification and cofactor addition. Two peroxidases were screened and identified from Escherichia coli BL21 (DE3), and tested in the enzymatic cascade...
April 24, 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/28435784/school-food-environment-quality-and-advertisement-frequency-of-child-oriented-packaged-products-within-walking-distance-of-public-schools
#6
Benjamin Missbach, Caterina Pachschwöll, Daniel Kuchling, Jürgen König
Food marketing for children is a major concern for public health nutrition and many schools make efforts to increase healthy eating. Food environments surrounding schools in urban areas may undermine these efforts for healthy nutrition within school programs. Our study aim is to describe the nutrition environment within walking distance of schools in terms of food quality and food marketing and to explore the degree to which elements of the nutrition environment varies by proximity to schools. In a cross-sectional study, we analyzed the surrounding food environments of a convenience sample of 46 target schools within 950m walking distance in 7 different urban districts across Vienna, Austria...
June 2017: Preventive Medicine Reports
https://www.readbyqxmd.com/read/28430558/lower-esophageal-sphincter-augmentation-for-gastroesophageal-reflux-disease-the-safety-of-a-modern-implant
#7
C Daniel Smith, Robert A Ganz, John C Lipham, Reginald C Bell, David W Rattner
INTRODUCTION: Use of the magnetic sphincter augmentation device (MSAD) for gastroesophageal reflux disease (GERD) is increasing. As this innovative treatment for GERD gains widespread use and adoption, an assessment of its safety since U.S. market introduction is presented. METHODS: Events were collected from the Manufacturer and User Facility Device Experience (MAUDE) database, which reports events submitted to the Food and Drug Administration (FDA) of suspected device-associated deaths, serious injuries, and malfunctions...
April 21, 2017: Journal of Laparoendoscopic & Advanced Surgical Techniques. Part A
https://www.readbyqxmd.com/read/28429917/the-impact-of-urbanization-on-the-community-food-environment-in-china
#8
Yang Wu, Hong Xue, Huijun Wang, Chang Su, Shufa Du, Youfa Wang
BACKGROUND AND OBJECTIVES: Research on how urbanization has influenced the food environment in China is limited. The study aimed to examine the impact of urbanization on the food environment in China. METHODS AND STUDY DESIGN: Longitudinal data collected during 1989-2009 from the China Health and Nutrition Survey were used, which covered 9 provinces in China. Urbanicity index (0-10) was assessed using an urbanicity scale. Final analyses included 216 communities...
May 2017: Asia Pacific Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/28429916/opportunities-and-barriers-to-public-health-nutrition-education-in-vietnamese-universities
#9
Quynh Th Pham, Anthony Worsley, Mark Lawrence, Bernie Marshall
BACKGROUND AND OBJECTIVES: A core challenge for low- and middle-income countries (LMICs) in combating the negative effects of the nutrition transition is to implement appropriate prevention strategies to halt the increasing prevalence of obesity and non-communicable diseases (NCDs), against a background of prevailing under nutrition. There have been several proposals for the enhancement of university nutrition education for future health and related professionals who are expected to communicate knowledge of health risks to the broad community...
May 2017: Asia Pacific Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/28428392/ecosystem-management-as-a-wicked-problem
#10
REVIEW
Ruth DeFries, Harini Nagendra
Ecosystems are self-regulating systems that provide societies with food, water, timber, and other resources. As demands for resources increase, management decisions are replacing self-regulating properties. Counter to previous technical approaches that applied simple formulas to estimate sustainable yields of single species, current research recognizes the inherent complexity of ecosystems and the inability to foresee all consequences of interventions across different spatial, temporal, and administrative scales...
April 21, 2017: Science
https://www.readbyqxmd.com/read/28427321/in-silico-assessment-of-biomedical-products-the-conundrum-of-rare-but-not-so-rare-events-in-two-case-studies
#11
Marco Viceconti, Claudio Cobelli, Tarek Haddad, Adam Himes, Boris Kovatchev, Mark Palmer
In silico clinical trials, defined as "The use of individualized computer simulation in the development or regulatory evaluation of a medicinal product, medical device, or medical intervention," have been proposed as a possible strategy to reduce the regulatory costs of innovation and the time to market for biomedical products. We review some of the the literature on this topic, focusing in particular on those applications where the current practice is recognized as inadequate, as for example, the detection of unexpected severe adverse events too rare to be detected in a clinical trial, but still likely enough to be of concern...
May 2017: Proceedings of the Institution of Mechanical Engineers. Part H, Journal of Engineering in Medicine
https://www.readbyqxmd.com/read/28425297/new-approaches-for-itaconic-acid-production-bottlenecks-and-possible-remedies
#12
Richa Bafana, R A Pandey
Currently, growing attention is being devoted to the conversion of biomass into value-added products, such as itaconic acid (IA), which is considered as the cleanest alternative to petroleum-based acrylic acid. IA is an unsaturated dicarboxylic acid that is used as a building block chemical for the production of several value-added products such as poly-itaconic acid. IA and its derivatives have a wide range of potential applications in textile, paint, pharmaceutical and chemical industries. Presently, industries are producing IA on the large scale by fermentation from glucose...
April 20, 2017: Critical Reviews in Biotechnology
https://www.readbyqxmd.com/read/28424409/clinical-genomic-profiling-to-identify-actionable-alterations-for-investigational-therapies-in-patients-with-diverse-sarcomas
#13
Roman Groisberg, David S Hong, Vijaykumar Holla, Filip Janku, Sarina Piha-Paul, Vinod Ravi, Robert Benjamin, Shreyas Kumar Patel, Neeta Somaiah, Anthony Conley, Siraj M Ali, Alexa B Schrock, Jeffrey S Ross, Philip J Stephens, Vincent A Miller, Shiraj Sen, Cynthia Herzog, Funda Meric-Bernstam, Vivek Subbiah
BACKGROUND: There are currently no United States Food and Drug Administration approved molecularly matched therapies for sarcomas except gastrointestinal stromal tumors. Complicating this is the extreme diversity, heterogeneity, and rarity of these neoplasms. Few therapeutic options exist for relapsed and refractory sarcomas. In clinical practice many oncologists refer patients for genomic profiling hoping for guidance on treatment options after standard therapy. However, a systematic analysis of actionable mutations has yet to be completed...
April 5, 2017: Oncotarget
https://www.readbyqxmd.com/read/28423943/high-value-added-lipids-produced-by-microorganisms-a-potential-use-of-sugarcane-vinasse
#14
Bruna Soares Fernandes, João Paulo Fernandes Vieira, Fabiano Jares Contesini, Paulo Eduardo Mantelatto, Marcelo Zaiat, José Geraldo da Cruz Pradella
This review aims to present an innovative concept of high value added lipids produced by heterotrophic microorganisms, bacteria and fungi, using carbon sources, such as sugars, acids and alcohols that could come from sugarcane vinasse, which is the main byproduct from ethanol production that is released in the distillation step. Vinasse is a rich carbon source and low-cost feedstock produced in large amounts from ethanol production. In 2019, the Brazilian Ministry of Agriculture, Livestock and Food Supply estimates that growth of ethanol domestic consumption will be 58...
April 20, 2017: Critical Reviews in Biotechnology
https://www.readbyqxmd.com/read/28423942/natural-gums-of-plant-origin-as-edible-coatings-for-food-industry-applications
#15
Anuradha Saha, Shvetambri Tyagi, Rajinder K Gupta, Yogesh K Tyagi
Natural plant-based gums and their derivatives are widely utilized in food industries, however, their applications as edible coatings to extend fresh fruits and vegetable shelf-life has been explored recently. These natural polymeric polysaccharides have many advantages as compared to synthetic polymers, because they are biodegradable, nontoxic, economical and easily available in the environment. Natural gums can also be semi synthetically modified to produce derivatives, which can easily compete with the synthetic preservatives available on the food market...
April 20, 2017: Critical Reviews in Biotechnology
https://www.readbyqxmd.com/read/28417173/semiautomated-taqman-pcr-screening-of-gmo-labelled-samples-for-unauthorised-gmos
#16
Ingrid M J Scholtens, Bonnie Molenaar, Richard A van Hoof, Stephanie Zaaijer, Theo W Prins, Esther J Kok
In most countries, systems are in place to analyse food products for the potential presence of genetically modified organisms (GMOs), to enforce labelling requirements and to screen for the potential presence of unauthorised GMOs. With the growing number of GMOs on the world market, a larger diversity of methods is required for informative analyses. In this paper, the specificity of an extended screening set consisting of 32 screening methods to identify different crop species (endogenous genes) and GMO elements was verified against 59 different GMO reference materials...
April 17, 2017: Analytical and Bioanalytical Chemistry
https://www.readbyqxmd.com/read/28416041/child-targeted-fast-food-television-advertising-exposure-is-linked-with-fast-food-intake-among-pre-school-children
#17
Madeline A Dalton, Meghan R Longacre, Keith M Drake, Lauren P Cleveland, Jennifer L Harris, Kristy Hendricks, Linda J Titus
OBJECTIVE: To determine whether exposure to child-targeted fast-food (FF) television (TV) advertising is associated with children's FF intake in a non-experimental setting. DESIGN: Cross-sectional survey conducted April-December 2013. Parents reported their pre-school child's TV viewing time, channels watched and past-week FF consumption. Responses were combined with a list of FF commercials (ads) aired on children's TV channels during the same period to calculate children's exposure to child-targeted TV ads for the following chain FF restaurants: McDonald's, Subway and Wendy's (MSW)...
April 18, 2017: Public Health Nutrition
https://www.readbyqxmd.com/read/28415920/what-can-the-food-and-drink-industry-do-to-help-achieve-the-5-free-sugars-goal
#18
Sigrid Gibson, Margaret Ashwell, Jenny Arthur, Lindsey Bagley, Alison Lennox, Peter J Rogers, Sara Stanner
AIMS: To contribute evidence and make recommendations to assist in achieving free sugars reduction, with due consideration to the broader picture of weight management and dietary quality. METHODS: An expert workshop in July 2016 addressed options outlined in the Public Health England report 'Sugar reduction: The evidence for action' that related directly to the food industry. Panel members contributed expertise in food technology, public heath nutrition, marketing, communications, psychology and behaviour...
April 1, 2017: Perspectives in Public Health
https://www.readbyqxmd.com/read/28415187/poverty-index-with-time-varying-consumption-and-income-distributions
#19
Amit K Chattopadhyay, T Krishna Kumar, Sushanta K Mallick
Starting from a stochastic agent-based model to represent market exchange in a developing economy, we study time variations of the probability density function of income with simultaneous variation of the consumption deprivation (CD), where CD represents the shortfall in consumption from the saturation level of an essential commodity, cereal. Together, these two models combine income-expenditure-based market dynamics with time variations in consumption due to income. In this new unified theoretical structure, exchange of trade in assets is only allowed when the income exceeds consumption-deprivation while CD itself is endogenously obtained from a separate kinetic model...
March 2017: Physical Review. E
https://www.readbyqxmd.com/read/28414950/a-nanobiosensor-composed-of-exfoliated-graphene-oxide-and-gold-nano-urchins-for-detection-of-gmo-products
#20
Zahra Aghili, Navid Nasirizadeh, Adeleh Divsalar, Shahram Shoeibi, Parichehreh Yaghmaei
Genetically Modified Organisms, have been entered our food chain and detection of these organisms in market products are still the main challenge for scientists. Among several developed detection/quantification methods for detection of these organisms, the electrochemical nanobiosensors are the most attended which are combining the advantages of using nanomaterials, electrochemical methods and biosensors. In this research, a novel and sensitive electrochemical nanobiosensor for detection/quantification of these organisms have been developed using nanomaterials; Exfoliated Graphene Oxide and Gold Nano-Urchins for modification of the screen-printed carbon electrode, and also applying a specific DNA probe as well as hematoxylin for electrochemical indicator...
March 6, 2017: Biosensors & Bioelectronics
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