Sentences with phrase «new safety data»

Also, EPA would no longer have to show that a chemical is potentially risky in order for the agency to request new safety data from companies.

Not exact matches

As activists from around the country gather in Washington to march for gun safety regulation, new data shows that the National Rifle Association has been aggressively resisting their message through online ads.
The new offering, «Watson for Patient Safety,» will gobble up anonymized medical records, claims data, and millions of electronic submissions to the FDA about potential drug side effects (known as individual case safety reports) to see if it can learn about the hidden dangers of medicines before they become too cSafety,» will gobble up anonymized medical records, claims data, and millions of electronic submissions to the FDA about potential drug side effects (known as individual case safety reports) to see if it can learn about the hidden dangers of medicines before they become too csafety reports) to see if it can learn about the hidden dangers of medicines before they become too costly.
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).
We assessed the data and from there developed a software tool that predicts the microbiological safety and stability of new formulations of shelf stable mayonnaises and dressings with reduced or alternative food acids, based on the company's own systems and processes.
For intelligent and networked data processing, at Interpack, Minebea Intec will be presenting a new software release for statistical process controls: SPC@Enterprise 3.0 converts all measurement data into useful information, even in the areas of foreign body detection and dynamic checkweighing, which help to ensure product quality, food safety and productivity.
A new Amazon - backed US study from Washington - based international nonprofit Family Online Safety Institute (FOSI) has found that 70 % of parents are comfortable with their child having a connected device or toy, but data privacy and safety guidelines are still an essential piece of the pSafety Institute (FOSI) has found that 70 % of parents are comfortable with their child having a connected device or toy, but data privacy and safety guidelines are still an essential piece of the psafety guidelines are still an essential piece of the puzzle.
To her credit, she acknowledges that Gaskin has no training of any kind, that one of her own children died at homebirth when she refused to seek medical attention for him and that The Farm is a new age cult, but Shapiro gives Gaskin a pass on far more than safety data.
The «potentially hazardous» category is confusing and misleading, check with your doctor - while some medications are definitely contraindicated, new data is constantly coming out about safety of different medications during breastfeeding.
A new study published this month in the journal Pediatrics had researchers poring over data collected from 4 observational studies about SIDS and sleep safety.
According to new data, 73 % of car seats are not used correctly; however, when used properly, child safety seats can reduce the risk of death by as much as 71 percent.
Schneiderman said data shows 1 - in - 3 residents of New York is «breathing dangerous levels of smog pollution» and the EPA's lack of action threatens citizens» health and safety.
In a statement she said analyzing this data may lead to new safety measures to better protect the safety of firefighters.
New data released by the pro-charter advocacy group Families for Excellent Schools shows NYPD school safety agents seized 1,678 weapons in the 2014 - 15 school year, up from 1,508 weapons in 2013 - 2014.
ALBANY — Governor Andrew Cuomo suggested he won't sign a «safety net» bill that would shield educators from consequences of the rough rollout of the Common Core standards in New York, citing new teacher - evaluation data released on TuesdNew York, citing new teacher - evaluation data released on Tuesdnew teacher - evaluation data released on Tuesday.
According to October 2017 data from the Institute for Traffic Safety Management and Research in Albany, there were 759 motorcyclist fatalities and over 20,000 injury crashes in New York between 2012 and 2016.
«The illegal sale of marijuana can not and will not be tolerated in New York State, but data consistently show that recreational users of marijuana pose little to no threat to public safety,» Cuomo wrote.
DOT would then institute new safety measures based on the data.
Using the first 18 months of flight data under the new system, Eurocontrol is updating its analysis of RVSM safety.
A new report by researchers at RTI Health Solutions (RTI - HS) and parent company RTI International, found that although healthcare databases have allowed for greater access to real world medical data, using databases to evaluate the safety of medical products is complex and requires careful research consideration.
To help our patients suffering from this disorder, we need to gather reliable data to evaluate the effectiveness and safety profile of new treatment options,» said lead study author Liang Zheng from the department of gastroenterology, the Second Jiangsu Provincial Hospital of Chinese Medicine, Nanjing University of Chinese Medicine.
Researchers compared inpatient discharge data from Massachusetts, New York and New Jersey between 2004 and 2009 and identified minority - serving hospitals and safety - net hospitals in each state.
The law requires no specific tests before a company brings a new product with a new chemical to market, and it does not require companies to release whatever safety data they may collect.
Lightning is not only about public safety — lightning strike data have recently been introduced into weather prediction, and a new UW study shows ways to apply them in storm forecasts.
The final order will become effective in 90 days, so manufacturers of new devices will need to start submitting data to the FDA about product safety before their products receive clearance to go on the market.
The new results add to previous data on the safety of melimine - coated lenses in animals, and provide initial evidence of their safety and comfort in humans.
Early results from a phase I, first in - human study indicate that a potential new class of drugs, RNA interference (RNAi) drugs, can be safely administered in humans, according to a researcher who presented data on the safety and preliminary efficacy of TKM - 080301 at the AACR Annual Meeting 2013, held in Washington, D.C., April 6 - 10.
The latest test, conducted on Feb. 22 at Spaceport America in New Mexico, provided a wealth of data essential for the safety of crews during re-entry into the atmosphere.
At the International Society for Stem Cell Research 2017 Annual Meeting (June 14 - 17, 2017; Boston, USA), Asterias Biotherapeutics, Inc (CA, USA) will present new 9 - month efficacy and safety data from their ongoing SCiStar Phase I / IIa trial of human embryonic stem cell - derived oligodendrocyte progenitor cells.
Asterias Biotherapeutics, Inc will present new 9 - month efficacy and safety data from their ongoing Phase I / IIa trial for OPC - 1 in a workshop and poster presentation.
While the long - term safety data for the first generation CXCR4 antagonists are not yet available, several new compounds are under preclinical development in an attempt to provide safer and more efficient treatment options for HIV and cancer patients.
Repurposing refers to the reuse of conventional drugs with distinct indications for new applications in order to speed up drug development by capitalizing on previous knowledge and safety data.
In this presentation, we discuss data from studies conducted with academic, clinical, and industry collaborators that demonstrates the utility of the system as a more predictive, human - relevant alternative for efficacy and safety testing of new chemical entitites.
Published new efficacy and safety data from preclinical studies of AST - OPC1 in the peer - reviewed journal «Stem Cells Translational Medicine.»
The OS data are consistent with that seen in PFS, with no new safety concerns,» study coauthor F. Stephen Hodi, MD, professor of medicine at Harvard Medical School in Boston, told Cancer Network.
Whilst patient benefit should be the focus of the Genomic Medicine Service, income generated from NHS data can be reinvested in the NHS to benefit future patients; Genomics England should continue to provide industrial and academic access to these data to facilitate the growth of the UK genomics industry and the development of new treatments, while ensuring consent and data safety safeguards.
How new technologies could be introduced into clinical practice and how data storage and safety can be dealt with was some of the topics of the Clinical Genetics Day, organised by SciLifeLab.
Partnership to adopt Organ - Chips to provide human - relevant data in drug discovery and development aiming to reduce animal testing, and to implement personalized safety testing of new drug candidates
Starting with safety and traffic management as basic concerns, ITS is reaching out to three new domains: energy management, personalized mobility services navigated by big data, and resilient transport systems.
New dietary ingredients require a much more robust presentation of data to prove their safety, he adds.
If you see any suspicious content, press the avatar of it's author and then «Complain» - Straight personalities may be banned from chats marked as «lesbians only» or «gays only», as well as gays and lesbians may be banned from «straight only» places - This app can be used for random chatting with strangers, but it is restricted to trade nudes with the people you do not know as they may be offended - Horny adults are not welcome to use this app for sexting purposes, as you may be easily banned from the system for sharing inappropriate sexually explicit content with strangers during your text role play games - For your own safety reasons it is forbidden to mention any personal data, including other social networking or dating apps - Follow the General User agreement: you ready to start meeting new people online, having fun and killing time?
This is 3 Spreadsheets (outline only, to give guide) each with Year 7 - 9 (But can be used for KS2 up) outline for a Road Safety Project to include: Asking them to create: - Posters - Leaflets - Data to show in different forms - Animation - Video Using several different programs either familiar or new.
The more than 30 pages of proposed rules for the Family Educational Rights and Privacy Act, or FERPA, include protections for educators who seek to share information to protect a student's health or safety, new guidelines for school districts on sharing student data with educational researchers, and a proposed requirement that schools safeguard electronic and other records, including from some school staff members.
Rockoff and Lockwood also examined survey data on New York City parents whose children attended both types of schools and found that parents whose children attend K - 8 public schools rated their schools higher on education quality, academic rigor and school safety compared to parents whose children attend stand - alone middle schools.
LGfL is providing teachers with a trackable, data - rich, competence - based online safety assessment and training tool; at the heart of this innovation is a new approach.
Educators 4 Excellence - New York reacts to Mayor de Blasio and NYPD's release of student safety data
A quick trip through the Principal magazine archive illuminates the point, with a 1991 technology - themed issue focused on what were then new technology tools — «electronic mail» and a portable «computer in your lap» — while a 1997 issue addressed topics that are still evolving, such as teacher training, data safety, digital literacy, and infrastructure.
A new report out of New York City suggests that policy makers should identify troubled schools by their absenteeism rates — a relatively easy data point to obtain — and then work to fix the schools by addressing each one's unique problems, from homelessness and child abuse to teacher turnover and safenew report out of New York City suggests that policy makers should identify troubled schools by their absenteeism rates — a relatively easy data point to obtain — and then work to fix the schools by addressing each one's unique problems, from homelessness and child abuse to teacher turnover and safeNew York City suggests that policy makers should identify troubled schools by their absenteeism rates — a relatively easy data point to obtain — and then work to fix the schools by addressing each one's unique problems, from homelessness and child abuse to teacher turnover and safety.
In a report on school safety released last October, Eden reached the conclusion that New York City's charter schools were «safer» than traditional district counterparts not by comparing raw data from the Big Apple's school climate survey or even using more - objective data such as incident reports over a period of several years.
The new implementation grants can be used to coordinate education, health, and safety services; increase family engagement in student learning; improve learning inside and outside of school; secure additional and sustainable funding sources; and establish data systems to record and share the community's progress.
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