Sentences with phrase «reviewing safety data»

After reviewing safety data on a range of anti-inflammatory drugs, the Food and Drug Administration on April 7 asked Pfizer to remove its prescription pain medication valdecoxib (Bextra) from the market.

I personally have reviewed the safety data and the evidence that's put together when these foods are about to be put into the general marketplace, and I find that these foods are completely safe.

Not exact matches

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

Providers and regulators can also use social media data to monitor performance in real time, using natural language processing and machine learning to scan consumers» text reviews for keywords of interest related to patient safety.

The members of the SAB critically review data, publications and government reports with respect to the safety and health consequences of the use of food and beverage packaging materials, upon request by GPI, and advise GPI and its members with respect to these issues.

The national rice institutes plan to submit all safety information to government regulators who will review these data as part of the approval process for Golden Rice before it can be made available to farmers and consumers.

ICRR plans to submit all safety information to government regulators who will review these data as part of the approval process for Golden Rice before it can be made available to farmers and consumers.

Under the current system, chemical companies perform safety tests or farm them out to contractors, then submit data for review at the Environmental Protection Agency (EPA) and other agencies.

They had to come up with an idea, submit a proposal, pass a competitive peer review at NASA, raise money, design the equipment, put it together, make sure it passed NASA's rigorous safety precautions, and, of course, collect data on the flight — all work for which they received no course credit.

The Fukushima accident has produced «a mountain of data» on safety issues that should be considered by the NRC staff reviewing the AP1000, Warren said.

The study experienced very rapid enrollment and at the preplanned independent data and safety monitoring review panel, the study was stopped early only 10 months after the study commenced because it met the primary endpoint of improving progression - free survival (time to cancer relapse).

Data for the study was obtained from dozens of published peer - reviewed scientific studies and the Xylem Functional Traits Database, which contains measurements of the hydraulic safety margins for each species as determined through laboratory experiments.

It should begin by reforming and strengthening the Toxic Substances Control Act to require reviews of chemicals for safety, force manufacturers to provide adequate health data on any chemical under review, and empower agencies to restrict or ban the use of chemicals with clear evidence of harm.

Patient safety is paramount to us and after a review of these results and in consultation with our Data Monitoring Committee, a team of independent experts who monitor the trial's safety results, we decided to continue the trial but pause additional enrollment while we do further analysis.

data safety monitoring board (DSMB)- an independent group that reviews data during the study and can recommend a study to be stopped if it appears the volunteers are being placed at risk.

She has served on several university committees including the Scientific Review Committee, the Institutional Review Board and the Data Safety and Monitoring Board.

(English) Multiple reviews found no concerns related to the integrity of the study data, the accuracy of the research results or the safety of the research subjects.

Published new efficacy and safety data from preclinical studies of AST - OPC1 in the peer - reviewed journal «Stem Cells Translational Medicine.»

PD01A in Phase I: Early Evidence of Safety and Hints of Efficacy The animal data reviewed above were published in June of 2014, [15] long after they had evidently been completed (see e.g. [11]-RRB-.

Throughout a trial like this, an independent committee of experts regularly reviews all the safety data to look for any sign of danger or harm.

We provide access to multiple data bases of authoritative, up to date reviews on the evidence and safety for the use of herbs, supplements, vitamins, and minerals, as well as other complementary medicine modalities.

«Review of Novartis safety data has failed to detect an increased risk in sudden cardiac death associated with methylphenidate use.»

The protocol was approved by the institutional review boards at the Harvard T.H. Chan School of Public Health, Brigham and Women's Hospital, and the Pennington Biomedical Research Center of the Louisiana State University System, as well as by a data and safety monitoring board appointed by the National Heart, Lung, and Blood Institute.

This study was approved by the University of Texas Medical Branch Institutional Review Board and independently reviewed by a data safety and monitoring board.

Ofsted data from 84 schools inspected about online safety in 2015 and self - review data from 7,000 schools using 360 Degree Safe has found that while schools are on the whole very strong when it comes to e-safety policies and filtering, they are weaker on staff and governor training, pupil involvement and evaluating impact of e-safety policies and practice.

It's also important that a school reviews all of its policies to ensure they are all in accordance with the Health and Safety, Data Protection, Risk Management and Freedom of Information Acts.

Table of contents: The Copyright, Designs and Patents Act 1988 The copyright of algorithms The Computer Misuse Act 1990 The Data Protection Act 1998 The Health and Safety at Work etc Act 1974 The Freedom of Information Act 2000 Human Rights Act 1998 Hackers v crackers Wireless networking Cloud storage and cloud computing Asking ethical questions Data privacy Wearable technology Computer based implants Healthcare apps Review culture Environmental impact of technology Answering long exam questions Other workbooks in this series: * Fundamentals of Algorithms GCSE revision student workbook Programming Fundamentals of Data Representation GCSE revision student workbook * Computer Systems GCSE revision student workbook Fundamentals of Computer Networks GCSE revision student workbook Cyber Security GCSE revision student workbook

Ofsted data from 84 schools inspected about online safety in 2015 and self - review data from 7,000 schools using 360 Degree Safe has found that while schools are on the whole very strong when it comes to online safety policies and filtering, they are weaker on staff and governor training, pupil involvement and evaluating impact of online safety policies and practice.

A review by Skiba and Losen, in the Winter 2015 - 2016 edition of American Educator, cites data showing schools with higher rates of suspension have poorer safety and climate, and students with more suspensions are more likely to have future antisocial behaviors and more suspensions.»

A key mechanism for determining the effectiveness of this proficiency - based system is the use of Education Quality Reviews that incorporate quantitative and qualitative data in five dimensions of school quality: academic achievement, personalization, safety and school climate, high - quality staffing, and financial efficiencies.

SAFETYNET — Allows federal and state safety personnel to access, report, and analyze data obtained from inspections, crashes, compliance reviews, motor carrier complaints, and the motor carrier census.

The 81 recommendations made by NFAC, now under review by the Department, include suggestions to improve safety and security across the freight rail network, highlight funding needs and challenges, and call for increased streamlining processes and better collection of data and research.

As part of FMCSA's work to make safety data readily available to the traveling public, the SaferBus mobile app gives bus riders a quick and free way to review a bus company's safety record before buying a ticket or booking group travel.

From the funds authorized by this subsection, the Secretary shall ensure that a review is completed on each motor carrier that demonstrates through performance data that it poses the highest safety risk.

You should review our Connected Vehicle Services Privacy and Protection Notice at www.toyota.com/privacyvts for an explanation of our collection and use of your Vehicle Data and Personal Information for Toyota Safety Connect ®.

This ranking is based on our analysis of published reviews and test drives of the Toyota Sienna, as well as reliability and safety data.

An overall picture could be gleaned from a review of crash data from the National Highway Traffic Safety Administration (NHTSA), hospital emergency department records, death certificates, and media sources.

«The winning cars, SUVs, and minivans have the best combination of positive reviews from professional automotive writers, passenger and cargo space, excellent safety and reliability data, and available family - friendly features.»

The 2014 Sonata Hybrid has noticeable improvements and has ranked 3rd out of 20 Affordable Midsize Cars (based on U.S. News» analysis of 19 published reviews and test drives as well as their analysis of reliability and safety data).

We do not choose vaccines based on price, but on efficacy and safety data that we review regularly.

After choosing the desired type of transportation and pay the corresponding amount, you will receive a confirmation coupon in your email, with your personal and flight data, which we ask you to review, print and bring with you to present it at time of service.The price displayed includes all airport taxes and fees, and full travel insurance to guarantee your safety while traveling with us; you won't need to make any extra payments.

To all those who dive Thailand, individual Shipwreck accounts concerning Thai wreck diving with detailed up - to - date dive site reviews from experienced local Thai and Western divers, technical dive planning software, Important dive site safety information and Historical research data concerning the events that caused the vessel's loss, will open up a wealth of information plus identify how to dive dozens of Thailand's more obscure and interesting wreck diving sites.

«In some cases, such as with some kinds of flame retardants, the initial EPA review was hindered by the lack of safety and exposure data.

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.

Issues referred to in the Vestas presentation were commented on in the previously mentioned peer - reviewed paper by Professors Moeller and Pedersen published six years after the Vestas presentation, where they stated «that minimum distances to dwellings are often calculated from noise data that lack an appropriate safety margin.

From Civil Eats: «Maricel Maffini [author of a 2013 study on data gaps in toxicity testing of chemicals allowed in U.S. foods] suggests the FDA's current system of approving food additives could be improved by requiring additive safety to be reviewed periodically and by basing safety information on how much people actually eat.»

During the past 18 months, the firm represented four families at an inquest into the death of five service personnel killed in a helicopter crash in Afghanistan, which led to a recommendation that safety rules should be reviewed and all military aircraft fitted with flight data recorders.

Our attorneys will thoroughly investigate your accident, reviewing witness statements, citations, driver logs, toll booth and gas station receipts, weigh station records, GPS data, and other evidence to prove a driver violated hours of service or other regulations, and determining if a trucking company pushed its drivers to put in more miles than safety allows.

State of the art knowledge about the execution of safety reviewing procedures and communicating technical data in layman's language

Reviewed lab reports and clinical data; contacted sites and discussed laboratory results and actions necessary to ensure protocol consistency and patient safety.