Sentences with phrase «product safety studies»

Not exact matches

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).
The new gluten threshold and sampling plan outlined in the study provides valuable guidance to processors and enhances the safety of whole grain products certified by GFCO for consumers.
Eagle's «Meat Safety Assured Through X-ray Inspection» case study explains how installing an Eagle ™ FA 720 Bulk is enabling the company to supply a premium product to its grinders at the pace required to stay ahead of the game.
Eagle case studies exist to educate manufacturers and all members of the supply chain about product safety and quality regulations and to explain the benefits offered by implementation of a certified product inspection system.
To look into this safety question, the Gluten Intolerance Group (GIG) recently conducted a pilot study at the University of Chicago's Celiac Research Center to investigate whether these beer options are truly free of detectable gluten, making them a product that consumers can confidently select.
«Energy drinks have been safely consumed by people around the world for more than 25 years and nothing in this study of just 18 people refutes the safety of these products or their ingredients.
The Court of Appeals stated that there is no full scientific evidence that will ascertain the safety of the product, and that there is no single law that governs the study, introduction and use of GMOs.
«The evidence - based research published by our Center, which has been confirmed by studies from colleagues around the world, conclusively supports the 20 ppm level as a suitable safety threshold for gluten - free products
The threshold and sampling plan provided in the study will help consumers of GFCO certified products by enhancing the safety of whole grain foods.
A study by the Consumer Product Safety Commission (CPSC) concluded that padded goal posts significantly reduced the number and severity of such injuries, and were especially effective in reducing head injuries.
This is a study done by the Consumer Product Safety Commission http://www.cpsc.gov/library/shopcart.html It was done several years ago, but the facts are as relevant as ever, and more importantly, are not coming from me.
To U.S. Consumer Product Safety Commission See also: REVIEW OF NUMEROUS SIDS STUDIES THROUGH 2005 September 30, 1999 Ann Brown U.S. Consumer Product Safety Commission Office of Information and Public Affairs Washington, DC 20207 Dear Ann Brown, Your warning against placing infants in adult beds is highly erroneous, irresponsible, and will lead...
As a result of this and other studies, the AAP has issued an official safety warning against the use of crib bumpers, deriding the popular product as both dangerous and unnecessary.
A study by Washington University's department of pediatrics in St. Louis, published in The Journal of Pediatrics, analyzed three databases from the U.S. Consumer Product Safety Commission for deaths related to crib bumpers from 1985 through 2005.
A study from Washington University's department of pediatrics in St. Louis, published in The Journal of Pediatrics, analyzed three U.S. Consumer Product Safety Commission databases for deaths related to crib bumpers from 1985 through 2005.
«Product safety and transparent labeling has been our mission for over a decade, and we are honored that the Chemical - Free study names Earth Mama products
Although the makers of pregnancy teas promote their products as healthy for expectant moms, no clinical studies support these claims, and the safety of the ingredients is not regulated.
In May 1999, the Consumer Product Safety Commission [CPSC] released a warning against cosleeping or putting babies to sleep on adult beds that was based on a study of death reports of children under the age of two who had died from 1980 to 1997.
The study analyzed non-fatal incidence data from the National Electronic Injury Surveillance System with cost estimates from the Consumer Product Safety Commission's Injury Cost Model, and 1999 - 2013 fatal incidence data from the National Vital Statistics System.
Northfield Laboratories, Inc., in Evanston, Ill., has been conducting clinical trials for its oxygen - carrying red blood cell substitute, PolyHeme, but in May said the product failed to meet the primary goals of mortality and safety in an important phase III study.
Paul DeLeo, associate vice president, environmental safety at the American Cleaning Institute, which represents cleaning product manufacturers, said the study raises «unjust concerns.»
According to Dr Won Park, Inha University Hospital, Korea, and lead investigator of the PLANETAS study, «the challenge for biosimilars is to demonstrate similarity in therapeutic effectiveness, safety and immunogenicity to their reference product, not just biochemical and pharmacokinetic equivalence.»
On small scales, substances often behave much differently than they do in their familiar forms, and toxicology and safety studies of these products are still in the early stages.
In a first round of tests, arsenic levels in all the products Jackson's group studied fell within the 10 parts per billion safety limit the EPA sets for water.
This study utilized the National Electronic Injury Surveillance System (NEISS) database, which is managed by the Consumer Product Safety Commission (CPSC) and collects information on emergency room patients from 100 U.S. hospitals.
While these publications contain helpful articles, a new study found a surprising number of advertisements appearing in the nation's top magazines for parents showed images or products that contradicted health and safety recommendations from the American Academy of Pediatrics (AAP).
«Certainly it is a very good antimicrobial product,» says Zhiqiang Hu, a civil and environmental engineer at the University of Missouri — Columbia, who is studying the safety of silver nanoparticles.
The standard pharmaceutical development path for products that target pathogens moves slowly from studying safety, dosing, and biological responses in hundreds of people to an expensive efficacy trial with thousands of participants at high risk of becoming naturally infected.
Gabb emphasized that the study examines the presence of potentially harmful chemicals (as determined by various authoritative sources like the EPA and NIH) in consumer products, but that it makes no value judgments regarding the safety of the chemicals themselves.
Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes.
The complexity of the development of cells and gene therapy products are addressed by designing tailored studies to allow safety assessment of GTMPs and to fulfil GLP requirements and OECD principles.
«From the chemical standpoint,» the critical difference between «efficient» native diets and diets characterized by the «displacing foods of modern commerce,» according to Dr. Price, was that «all the efficient dietaries were found to contain two to six times as high a factor of safety in the matter of bodybuilding material, as the displacing foods» (emphasis added).11 The foods that served a «bodybuilding» purpose varied substantially according to the group and location studied, but in all instances, traditional societies emphasized the most nutrient - dense land and sea animal and plant foods that could be obtained in their context, ranging from the exceptionally high - vitamin dairy products, whole rye sourdough bread and occasional meat of the isolated Swiss to the fish, cereals and sweet potatoes of Kenya's Maragoli tribe.
Scientific studies were done regarding the safety of Remifemin Natural Hormone Free Menopause Support show that the product is safe to use even for those with breast cancer concerns.
A 2009 study by a researcher from the Chinese University of Hong Kong published in the journal Drug Safety cautions that herbal anti-obesity products can have serious dangers.
Instead a review of studies headed by Ian C. Monro comes to the following conclusion: «Whereas results in some studies are limited or conflicting, when viewed in its entirety, the current literature supports the safety of isoflavones as typically consumed in diets based on soy or containing soy products [emphasis ours].»
Researchers from the University of Michigan School of Public Health reviewed 27 studies examining the safety and effectiveness of antibacterial products containing the active ingredient triclosan.
Study Island's technology products offer educational information with testing material providing up - to - date knowledge of Internet safety issues.
The Canadian Food inspection Agency, which has studied consumer attitudes over food safety, says concerns include short - weighting products, substitute ingredients and false or misleading manufacturer claims.
Using scientific testing, we study pet products and author safety standards to measure whether pet products provide the level of protection claimed by advocates and intended by the manufacturer.
Although this study was conducted by Tufts University researchers, their findings are questionable as to the overall safety of this product.
* Breaking news: study shows unsafe levels of toxic heavy metals in pet food * Aflatoxin caused illness in recalled Kroger pet foods * FDA seeking comments on proposed PETNet * Food Safety Bill signed into law * Small animals re-protected * Bottled water report * Medicated topical creams for people can harm pets * Nordic Naturals introduces new fish oil products for pets 2.
We have many people inquire about natural oils especially in cats — I have many Vets also that have inquired about our various ingredients including NEEM oil — and after we explain that less then 1 / 100th of the formulation is made up of any of our essential oils they are very pleased with the concentration — especially when in our recommended usage less then 1 / 3rd of a teaspoon is recommended in very small breed dogs and cats — now take 1 / 100th of that and when it is used daily for the first 30 days on serious conditions with a topical application, and then the maintenance phase is one application every 3 to 4 days — the actual amount of any of our essential oils is very very small — and to add to the safety issue as I mentioned earlier it is a topical application and yes some is ingested — but with approximately 700,000 bottles used — and not one reported case of injury or death we have a fantastic record when compared to anesthesia scaling — according to the statistics reported in a very large study of 2,500 dogs — going under anesthesia — if the same 700,000 using our product chose anesthesia scaling instead according to the study — 2,358 would have died and 12 % or another 60,000 would have been injured!!!
The food safety risks have been documented in a study relied on by the New Mexico Attorney General in reaching his decision that products of horse slaughter are not safe for human consumption and illegal under state law.
Also, bear in mind that caution is necessary when selecting a neutraceutical product as these are not licensed or regulated in the same way that prescription canine pharmaceuticals are, so choosing a reputable company with safety and efficacy studies to back up their products is essential.
All of the animalEO products would fall into the category of «These products have not been evaluated for use with pregnant or breeding animals» - as we have not done scientific studies to prove toxicity or safety of the individual products.
Additionally, a 9 - month study in which Galliprant was administered to healthy dogs at approximately 15 times the labeled 2 mg / kg dose, demonstrated the product's safety.
A paper reporting a «rigorous double blind» study — the VIGOR trial — was submitted to NEJM in 1998, got through peer review at one of the most up - tight journals in the world of medicine, and — by way of cherry - picking the data submitted (selecting out some study subjects whose adverse events histories which, if considered, would've significantly affected the safety profile for rofecoxib and revealed something that Merck really didn't want us prescribers to learn about their «blockbuster» product — was published to be touted by Merck's marketing weevils as solid proofs of Vioxx's tolerability, efficacy, and safety.
In addition to the formidable achievement of turning car insurance into a cult product (you have to check out ilovesheilas to see for yourself), Sheilas» Wheels takes care of their female market by studying the particular safety issues women drivers face.
Some studies have shown that co-sleeping increases the risk of sudden infant death syndrome (SIDS) and isn't recommended by the Consumer Product Safety Commission or the American Academy of Pediatrics, but proponents claim that studies into the correlation between co-sleeping and SIDS are flawed and biased.
Insert Title — Duties & Responsibilities Serve as art director, press manager, photographer, IT assistant, maintenance technician, and customer service rep Manage corporate art / advertising department and oversee more than 270 orders per day Create publication layouts, promotional campaigns, advertisements, and other collateral for varied clientele Conceive photography concepts, settings, and capture engaging images for company projects Oversee project timelines, staff workflows, quality control, and staff development programs Perform maintenance on digital printing equipment ensuring cost effective and professional operations Design and implement corporate safety protocols as Safety Committee Co-chairman Assist IT department with computer maintenance, network administration, and troubleshooting Oversee customer service operations ensuring client satisfaction with corporate art products and services Implement methods to reduce costs while enhancing team productivity Skilled in PC, Mac, Microsoft Office Suite, Photoshop 5 - CS5, Corel Draw 9 - x3, Illustrator 8 - CS3, Poser 8, In - Design CS, and Adobe Acrobat Proficient in Nikon D Series, Roland Versa Cam, Encad Wide Format, Acuity UV 2504, Presstek 34 DI, Xenetech Laser Engraver, and Epson Printer Proof Certified welder, forklift operator, heavy equipment operator, and air compressed systems technician Study internal literature to become an expert on products and services Consistently promoted due to excellence in team management, art production, and dedication to company values Represent company brand with poise, integrity, and posisafety protocols as Safety Committee Co-chairman Assist IT department with computer maintenance, network administration, and troubleshooting Oversee customer service operations ensuring client satisfaction with corporate art products and services Implement methods to reduce costs while enhancing team productivity Skilled in PC, Mac, Microsoft Office Suite, Photoshop 5 - CS5, Corel Draw 9 - x3, Illustrator 8 - CS3, Poser 8, In - Design CS, and Adobe Acrobat Proficient in Nikon D Series, Roland Versa Cam, Encad Wide Format, Acuity UV 2504, Presstek 34 DI, Xenetech Laser Engraver, and Epson Printer Proof Certified welder, forklift operator, heavy equipment operator, and air compressed systems technician Study internal literature to become an expert on products and services Consistently promoted due to excellence in team management, art production, and dedication to company values Represent company brand with poise, integrity, and posiSafety Committee Co-chairman Assist IT department with computer maintenance, network administration, and troubleshooting Oversee customer service operations ensuring client satisfaction with corporate art products and services Implement methods to reduce costs while enhancing team productivity Skilled in PC, Mac, Microsoft Office Suite, Photoshop 5 - CS5, Corel Draw 9 - x3, Illustrator 8 - CS3, Poser 8, In - Design CS, and Adobe Acrobat Proficient in Nikon D Series, Roland Versa Cam, Encad Wide Format, Acuity UV 2504, Presstek 34 DI, Xenetech Laser Engraver, and Epson Printer Proof Certified welder, forklift operator, heavy equipment operator, and air compressed systems technician Study internal literature to become an expert on products and services Consistently promoted due to excellence in team management, art production, and dedication to company values Represent company brand with poise, integrity, and positivity
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