Proposed legislation currently in the House of Representatives would close that loophole by allowing the FDA to order additional
safety studies on medical devices like surgical mesh before approving them.
The FDA has not conducted
safety studies on GM foods.
The bill is meant to give the Environmental Protection Agency time to conduct
a safety study on hydrofracking and it's effects on the environment and watershed.
As the country awaits results from a nationwide
safety study on the natural gas drilling process of fracking, a separate government investigation into contamination in a place where residents have long complained that drilling fouled their water has turned up alarming levels of underground pollution.
The rule also addresses NTSB recommendations issued in response to an NTSB
safety study on integrity management and investigations of the 2010 gas pipeline explosion in San Bruno, California that killed 8 people and destroyed 38 homes and the 2014 rupture in Sissonville, West Virginia, that destroyed 3 homes and closed Interstate 77 for 19 hours.
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.
Much of that data is available
on its website and is part of the toolkit scientists use to
study the health,
safety, and future of the planet.
New
studies on oil and gas
safety issues tumbled out this week as if their authors were scrambling to trigger their year - end performance bonuses.
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).
Presentations will highlight the short and long - term effects of Ingrezza
on tardive dyskinesia symptoms by body region, long term
safety and efficacy data from the KINECT 4 phase 3 open label
study and also from RE-KINECT (real - world screening
study of patients with possible TD).
Alchemy of Finance You Can Be a Stock Market Genius Buffett's Letters to Investors Security Analysis Market Wizards series Margin of
Safety Michael Burry's Case
Studies Art of Short - Selling One Up
on Wall Street Global Macro Trading Forecasting Exchange Rates Quality of Earnings
This article and accompanying infographic breaks down the results and revelations of these independent scientific
studies on shaving and how these findings support traditional wet shaving with a single blade razor (i.e.
safety razor or straight razor).
Their
study found that Americans waste 160 billion pounds of food each year — often because of simple misunderstandings about expiration dates: Many Americans refuse to consume food after the dates
on packaging passes, even though in many cases, the dates have nothing to do with food
safety.
A Texas Workforce Commission
study on the technology's impact produced statistics that showed considerable improvements in
safety — and to the bottom line.
Yet in a 2006
study published by Food Protection Trends
on the rankings of
safety problems across all food sectors, 94 percent of
study respondents identified «deficient employee training» as the biggest
safety issue.
Although the cancer
study has been challenged by the European Food
Safety Agency (a group that has strong food industry ties), I will side with the unbiased Center for Science in the Public Interest
on this one.
Yet in a 2006
study published by Food Protection Trends
on the rankings of
safety problems across all food sectors, 94 percent of
study respon dents identified «deficient employee training» as the biggest
safety issue.
Many of our industry's leading food manufacturers and retailers, as well as international food
safety and quality standards now require that their suppliers undertake a detailed
study of their supply chain in accordance with GFSI guidance
on food supply chain vulnerability.
Worst of all, President Bush (George Herbert Walker, not his son) signed an executive order stating that no
safety studies are needed
on GMOs because the food producer bears ultimate responsibility «for assuring
safety.»
Out of concern for our customers and our concern for
safety as a whole, we had a toxicity
study performed based
on the highest levels of tungsten found in our rice protein drinks.
This
study was based
on an uncertainty factor of 100 times or more in magnitude so we are very confident our rice proteins are not a risk to
safety.
Dietician Keli Hawthorne says, «There are no
studies on the
safety of raw honey during pregnancy, but there is no reason it shouldn't be safe,» explaining honey doesn't carry listeriosis (found in unpasteurized cheeses and deli meats) which can cause serious infections in those with weakened immune systems, including pregnant women.
In any case, there are no
studies done
on the relative
safety of UC, so it can not be unequivocally stated that UC is more dangerous than midwife - assisted home birth.
Check out the child
safety sections of your vehicle owner's manual, and
study up
on relevant features like belts and seats.
On November 14, 2012, the Family Online
Safety Institute released a new
study conducted by Hart Research Associates and supported by Microsoft and Google.
Many
studies that have been done have focused
on the
safety of co-sleeping for the child, but there isn't a lot of research
on how co-sleeping affects parents.
A new
study from the Family Online
Safety Institute, a nonprofit on a mission to «make the online world safe for kids and families,» found that teens are not only more connected than ever, increasingly using mobile devices and social networks, but they understand privacy and safety issues in a way that previous generations d
Safety Institute, a nonprofit
on a mission to «make the online world safe for kids and families,» found that teens are not only more connected than ever, increasingly using mobile devices and social networks, but they understand privacy and
safety issues in a way that previous generations d
safety issues in a way that previous generations didn't.
«Based
on current and available data, we have taken appropriate steps to help ensure the
safety of our football players, but as this remains an evolving area of
study, future research must be monitored, and our recommendations could then be revisited and revised.»
The
study adds to the body of large cohort
studies of planned home births that have reported
on the relative
safety of home versus hospital births.
The most amazing epidemiological
study on the
safety of formula has been going
on for decades, it's called «a large proportion of full term humans in the developed world», and there is currently no hard data that there are dangers, or even visible trends associated with formula.
However, there is currently a lack of
studies testing the
safety and effects of these herbs
on women with pregnancy constipation.
A new
study from the Family Online
Safety Institute (FOSI) reveals that the large majority of parents believe technology has a positive effect
on their child's future, career and life skills (78 %) and creativity (64 %).
Efforts to educate teens
on sun
safety appear to be gaining little or no traction: the same
study showed little change in sunscreen use in bi-annual surveys between 1999 and 2005.
Reflecting
on the evidence, the
study's authors wrote, «Despite the media attention and perceived benefits of these therapies, there are still limited data as to efficacy and long - term
safety.
Despite offering sound advice
on what to do, most parents in the research
study missed out
on opportunities to teach teens how to recognize potential
safety hazards
on their own.
Since there has never been any
study of the
safety of the BFHI or its medical indications for supplementation, there is no assurance that they protect babies from injury; in fact the evidence presented at the meeting
on these complications reveal that they do not.
While there is certainly a difference in physical
safety between checking
on a crying baby and shutting the door overnight, there are no «published
studies» telling us how long it is «safe» to leave a baby to cry.
In order to protect infant
safety and ensure the patient and human rights of mothers and babies, we have built a non-profit organization committed to: (1) the
study of exclusive breastfeeding complications that can result in brain injury and, in the most severe instances, death; and (2) raising public awareness to signs of infant hunger and the consequences that can result based
on peer - reviewed research.
Although no official stance has been adopted by health authorities
on the
safety of such pads, some
studies have connected number of infant deaths in the crib with suffocation or choking caused by bumper pads and the strings that attach them to the crib walls.
In that book Dr. Sears cites more than 250 current, reputable, scientific
studies on the
safety of sleep sharing when properly practiced.
In order to assess the efficiency and
safety of domperidone, researchers Catherine Paul et al. analyzed both the limited
studies available
on maternal and infant exposure to the stimulant as well as larger
studies focused
on its use in gastrointestinal disorder treatment.
After revewing dozens of
studies on crib mattress
safety, there is no evidence that one material is healthier (or more dangerous) than another... despite what you might read online!
International research
on safety of homebirths [1]: «In 2014, a comprehensive review in the Journal of Medical Ethics of 12 previously published
studies encompassing 500,000 planned home births in low - risk women found that perinatal mortality rates for home births were triple that of hospital births.
I suggest you look up a thorough debunking og what MANA posted are
studies that «prove»
safety of homebirth
on Honest Midwife's blog — she is a former CPM who analyzed these
studies and claims about them as part of her research paper.
Studies that have claimed the safety of out - of - hospital deliveries by using higher mean or high cut - off 5 min Apgar scores and reviews based on these studies should be treated with skepticism by obstetricians and midwives, by pregnant women, and by policy
Studies that have claimed the
safety of out - of - hospital deliveries by using higher mean or high cut - off 5 min Apgar scores and reviews based
on these
studies should be treated with skepticism by obstetricians and midwives, by pregnant women, and by policy
studies should be treated with skepticism by obstetricians and midwives, by pregnant women, and by policy makers.
To be absolutely certain our technology was the safest
on the market, we commissioned an independent
study by two of the country's leading optical
safety experts: Dr. David Sliney and Dr. Myron Wolbarsht.
Our
study adds to the body of large cohort
studies of planned home births that have reported
on the relative
safety of home versus hospital birth.
For those of you who are interested in finding out what the current science is
on the relative
safety of hospital versus nonhospital birth in the United States, here are some of the latest relevant
studies:
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.
National Institute of Child Health and Human Development:
Study Confirms
Safety of Placing Infants to Sleep
on Their Backs