Sentences with phrase «by the regulatory authority in»

A company that has got no experience in the industry and is not recognised by the regulatory authority in this country, that is the NPA, is being sole - sourced to manage a tank farm that contains our national strategic and security stocks, that begs a lot of questions and I think we need a better explanation from BOST».
Because all NETS are classified as rare diseases by regulatory authorities in the EU and the US, there are few drugs available to treat these patients.
Clifford Chance has deep knowledge and extensive experience in advising companies experiencing a dawn raid conducted by regulatory authorities in Europe, Asia and the United States.

Not exact matches

The costs differ by state, so you should check with the proper regulatory authority in your state.
These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.
(In fact, previous actions by Uber seem to flaunt the positions of regulatory authorities.)
While this underlines the risks of investing in pre-revenue companies, the good news is biotech is strictly regulated by national pharmaceutical regulatory authorities in the US, Europe and China, which is one reason that biotech made sense for our market.
a person that is recognized or designated by the securities regulatory authority, or, except in Ontario and Québec, the regulator as an accredited investor.
We do this by conducting clinical trials in which we collect safety and efficacy data about our experimental drugs with the goal of submitting those data to regulatory authorities, like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), so that these experimental drugs can be approved for use by patients.
And as part of the structural transformation of society urged by creditors, governments are to deregulate (or simply not put regulatory authorities in place) the sectors being privatized on credit.
Referring to the decision, a spokesman for Sweden's Financial Supervisory Authority said that «every institution must decide on the details of their internal regulations specifying the rules for their employees» investments and trading,» suggesting that the regulatory agency does not intend to interfere in Nordea's decision, nor act against similar moves that may be taken by other companies.
In addition, it is possible that future orders issued by, or enforcement actions initiated by, regulatory authorities could cause us to incur substantial costs or require us to change our business practices in a way that could seriously harm our businesIn addition, it is possible that future orders issued by, or enforcement actions initiated by, regulatory authorities could cause us to incur substantial costs or require us to change our business practices in a way that could seriously harm our businesin a way that could seriously harm our business.
The executives» corner - cutting on compliance adds to the embarrassment and regulatory headaches for Zurich - based Credit Suisse, which has had to pay billions of dollars of fines to U.S. authorities in recent years over a wide range of allegations, including mis - selling of mortgage - backed securities, deficiencies in its anti-money-laundering program, front - running clients on foreign - exchange trades and violating U.S. sanctions by secretly funneling money from Iran through American banks.
If we are required by the FDA, the EMA, or other regulatory authorities to perform studies in addition to those we currently anticipate, or if there are any delays in completing our clinical trials or the development of our current product candidates, our expenses could increase and our ability to generate revenue could be further delayed.
As part of our strategy to provide clearing services in the regulatory jurisdictions where you do business, ICE Clear Singapore is regulated by the Monetary Authority of Singapore.
Morrison Cohen will also track the regulatory pronouncements of the Securities and Exchange Commission, Commodity Futures Trading Commission, Financial Industry Regulatory Authority, and the New York State Department of Financial Services, in addition to «other regulatory announcements» including those made by executive order.
Unless we are prohibited from doing so by any applicable law, regulation, court order or instruction or guidance of a competent regulatory authority or agency, in terminating your account we may do any of the following at our sole discretion: A. transfer the funds back to the source; or B. convert your account balance to Bitcoins at our then - prevailing rate, subject to applicable fees and as soon as practicable give you 48 hours» notice that we intend to deactivate your account, requesting that you provide us with an alternative bitcoin wallet address to which we can transfer your bitcoin within that period (the «Redemption Period»);
The Dubai International Financial Center (DIFC) which is regulated by the Dubai Financial Services Authority (DFSA) is the major regulatory body allowing financial transactions in the UAE.
No securities commission or other regulatory authority has in any way passed upon this information and no representation or warranty is made by us to that effect.
As the first fintech internship scheme led by a regulatory authority and a research institute, banks and universities have joined force in developing talents for the fintech industry.
Wells Fargo Advisors is registered with the U.S. Securities and Exchange Commission and the Financial Industry Regulatory Authority, but is not licensed or registered with any financial services regulatory authority outside of the U.S. Non-U.S. residents who maintain U.S. - based financial services account (s) with Wells Fargo Advisors may not be afforded certain protections conferred by legislation and regulations in their country of residence in respect of any investments, investment transactions or communications made with Wells Fargo Authority, but is not licensed or registered with any financial services regulatory authority outside of the U.S. Non-U.S. residents who maintain U.S. - based financial services account (s) with Wells Fargo Advisors may not be afforded certain protections conferred by legislation and regulations in their country of residence in respect of any investments, investment transactions or communications made with Wells Fargo authority outside of the U.S. Non-U.S. residents who maintain U.S. - based financial services account (s) with Wells Fargo Advisors may not be afforded certain protections conferred by legislation and regulations in their country of residence in respect of any investments, investment transactions or communications made with Wells Fargo Advisors.
«The safety of low - kilojoule sweeteners used in diet drinks is supported by leading regulatory agencies throughout the world, such as the U.S. Food and Drug Administration, the European Food Safety Authority, the National Health and Medical Research Council, and Food Standards Australia and New Zealand — as well as leading health groups, including the Australian Diabetes Council and Dieticians Association of Australia.»
Like other foods and beverages sold in the United States, energy drinks and their ingredients are regulated by regulatory authorities.
The field trials were permitted by and followed the safety standards of the DA - Bureau of Plant Industry (DA - BPI), the national regulatory authority in the Philippines for biotechnology research and development.
In addition, all Golden Rice field trials in the Philippines are conducted under permits issued by the Bureau of Plant Industry of the Department of Agriculture (DA - BPI), the national regulatory authority in the Philippines for crop biotechnology R&D, after they established that the trials will pose no significant risks to human health and the environmenIn addition, all Golden Rice field trials in the Philippines are conducted under permits issued by the Bureau of Plant Industry of the Department of Agriculture (DA - BPI), the national regulatory authority in the Philippines for crop biotechnology R&D, after they established that the trials will pose no significant risks to human health and the environmenin the Philippines are conducted under permits issued by the Bureau of Plant Industry of the Department of Agriculture (DA - BPI), the national regulatory authority in the Philippines for crop biotechnology R&D, after they established that the trials will pose no significant risks to human health and the environmenin the Philippines for crop biotechnology R&D, after they established that the trials will pose no significant risks to human health and the environment.
The field trials were permitted by the Department of Agriculture Bureau of Plant Industry (DA - BPI), the national regulatory authority in the Philippines for crop biotechnology research and development, after establishing that the trials will pose no significant risks to human health and environment.
A number of factors could cause actual results or outcomes to differ materially from those indicated by such forward - looking statements, including but not limited to, (1) our ability to open new restaurants and food and beverage locations in current and additional markets, grow and manage growth profitably, maintain relationships with suppliers and obtain adequate supply of products and retain our key employees; (2) factors beyond our control that affect the number and timing of new restaurant openings, including weather conditions and factors under the control of landlords, contractors and regulatory and / or licensing authorities; (3) changes in applicable laws or regulations; (4) the possibility that the Company may be adversely affected by other economic, business, and / or competitive factors; and (5) other risks and uncertainties indicated from time to time in our filings with the SEC, including our Annual Report on Form 10 - K filed on March 30, 2016 and our Quarterly Report on Form 10 - Q filed on August 15, 2016.
«Necessary steps are being taken by the regulatory authorities to sanction the airline in a bid to prevent future occurrence.
And republicans, in addition, are concerned about many other issues: the discrimination faced by the LGBT community, consumers at the mercy of retailers or companies, Internet users at the mercy of providers or regulatory states, children at the mercy of their parents or teachers, the elder at the mercy of younger disrespectful citizens, the kid being bullied by a classmate at school, the prisoner abused by his jail mates or by the prison authorities, etc..
Government spokespeople say that this is all about evidence and procedure — it's all part of their «step - by - step» plan for the new regulatory body the Financial Conduct Authority It has happened now, they say, because of «growing evidence» from abroad that a cap can be successful in bringing down prices and protecting consumers.
Actually, all that statutory underpinning means is that the independent regulatory body would be established by legislation, in a manner similar to the Independent Parliamentary Standards Authority (IPSA) that now administers MPs» expenses, after they blotted their copybook on this score a couple of years ago.
The exam boards are overseen by three regulatory authorities: in England - Ofqual (Office of the Qualifications and Examinations Regulator); in Wales - DCELLS (Department for Children, Education, Lifelong Learning and Skills; in Northern Ireland: CCEA (Council for the Curriculum, Examinations and Assessments).
In a report out this week, the North American Electric Reliability Corp., a nonprofit regulatory authority charged by the federal government with oversight of reliability in U.S. power systems, found that it still lacked adequate analysis to know whether the plan's targets are achievablIn a report out this week, the North American Electric Reliability Corp., a nonprofit regulatory authority charged by the federal government with oversight of reliability in U.S. power systems, found that it still lacked adequate analysis to know whether the plan's targets are achievablin U.S. power systems, found that it still lacked adequate analysis to know whether the plan's targets are achievable.
Until World War II, the leading authorities on obesity (and most medical disciplines) worked in Europe and had concluded that obesity was, like any other growth disorder, caused by a hormonal and regulatory defect.
Dihydroartemisinin - piperaquine also became one of the few antimalarials to be formally registered by a stringent regulatory authority when the European Medicines Agency approved it for use in 2013.
Séralini's report in BioMed Research International describes how pesticides kill cultured human cells, with the hair - raising conclusion that pesticides may be vastly more toxic than assumed by regulatory authorities.
Tissue Genesis» Icellator ® is approved for use by medical regulatory authorities in South Korea, the Ukraine and the Bahamas, with ongoing FDA - cleared trials in the USA for multiple indications of chronic disease.
I invite each interested SEA to request this flexibility pursuant to the authority in section 9401 of the Elementary and Secondary Education Act of 1965 (ESEA), which allows me to waive, with certain exceptions, any statutory or regulatory requirement of the ESEA for an SEA that receives funds under a program authorized by the ESEA and requests a waiver.
In the face of a disaster or some other emergency situation, the FAA can and does use its regulatory authority and operational capabilities to sustain the NAS while supporting, often through the DOT - led Emergency Support Function 1 activities, response and recovery efforts undertaken by the Federal Emergency Management Agency and other Federal, State, local, tribal, and territorial interagency partners, as well as the private sector.
Important factors that could cause actual results to differ materially from those expressed or implied by such forward - looking statements include, without limitation, possible product defects and product liability, risks related to international sales and potential foreign currency exchange fluctuations, the initiation or outcome of litigation, acts or potential acts of terrorism, international conflicts, significant fluctuations of quarterly operating results, changes in Canadian and foreign laws and regulations, continued acceptance of RIM's products, increased levels of competition, technological changes and the successful development of new products, dependence on third - party networks to provide services, dependence on intellectual property rights, and other risks and factors detailed from time to time in RIM's periodic reports filed with the United States Securities and Exchange Commission, and other regulatory authorities.
Get more minutes for your buck Government regulatory authority Ofcom has announced a reduction in the call costs between the four major mobile phone companies in the UK, by up to 80 - percent.
Self - regulatory organizations (SROs): Private organizations owned and operated by their members and to whom the SEC delegates much of its authority to oversee both securities markets and participants in those markets.
Whether or not actual results and developments will conform to ProShare Advisors LLC's expectations and predictions, however, is subject to a number of risks and uncertainties, including general economic, market and business conditions, changes in laws or regulations or other actions made by governmental authorities or regulatory bodies, and other world economic and political developments.
The fees charged by E * TRADE related to a transaction for the account of Customer are designed to offset third - party fees generally charged to E * TRADE in respect of such transactions, including without limitation any regulatory or transaction fee or tax, market center fee, clearing house fee or depository fee, assessed by any regulatory authority, self - regulatory organization, market center, clearing house, clearing agency or depository, including without limitation the SEC, FINRA, any national securities exchange or other market center, DTC and NSCC.
As futures trading involves risks of both the parties not fulfilling their obligation, the futures market is highly regulated by regulatory authorities like SEBI in India.
In terms of regulatory oversight, Binary.com is regulated by the Malta Financial Services Authority as a Category 3 Investment Services provider under the license number IS / 70156.
The increased focus on fixed - income markets by market authorities has, however, recently resulted in several other regulatory initiatives, which are making retail bond investors more informed and ensuring the quality of their trade executions.
In addition the fact that they are not regulated by leading European financial regulatory bodies such as the UK's Financial Conduct Authority or the Cyprus Securities Exchange Commission tend to add more skepticism about Grand Capital reliability.
In addition given the fact that Forest Park FX is also regulated by the U.S financial regulatory authorities, they offer peace of mind to traders who have engaged its services.
Barclays and fifteen other global financial institutions came under investigation by a handful of regulatory authorities — including those of the United States, Canada, Japan, Switzerland, and the UK — for colluding to manipulate the Libor rate beginning in 2003.
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