Sentences with phrase «by the regulatory agency in»

As the compound in question isn't approved by any regulatory agency in the world for the condition indicated (psoriasis) then this really points to alternative explanations for the positive GHRP - 6 test.
The intent of that law is now being undermined by the regulatory agency in charge of its enforcement.
And the truth is, that's okay, because as long as the food meets AAFCO guidelines, then the food is deemed «nutritious» by the regulatory agencies in charge of protecting the consumer and their pet.
In early December, the bitcoin community welcomed the innovation - friendly policy and a new Digital Currency Regulatory Guidance presented by regulatory agencies in Illinois.

Not exact matches

Important factors that could cause actual results to differ materially from those reflected in such forward - looking statements and that should be considered in evaluating our outlook include, but are not limited to, the following: 1) our ability to continue to grow our business and execute our growth strategy, including the timing, execution, and profitability of new and maturing programs; 2) our ability to perform our obligations under our new and maturing commercial, business aircraft, and military development programs, and the related recurring production; 3) our ability to accurately estimate and manage performance, cost, and revenue under our contracts, including our ability to achieve certain cost reductions with respect to the B787 program; 4) margin pressures and the potential for additional forward losses on new and maturing programs; 5) our ability to accommodate, and the cost of accommodating, announced increases in the build rates of certain aircraft; 6) the effect on aircraft demand and build rates of changing customer preferences for business aircraft, including the effect of global economic conditions on the business aircraft market and expanding conflicts or political unrest in the Middle East or Asia; 7) customer cancellations or deferrals as a result of global economic uncertainty or otherwise; 8) the effect of economic conditions in the industries and markets in which we operate in the U.S. and globally and any changes therein, including fluctuations in foreign currency exchange rates; 9) the success and timely execution of key milestones such as the receipt of necessary regulatory approvals, including our ability to obtain in a timely fashion any required regulatory or other third party approvals for the consummation of our announced acquisition of Asco, and customer adherence to their announced schedules; 10) our ability to successfully negotiate, or re-negotiate, future pricing under our supply agreements with Boeing and our other customers; 11) our ability to enter into profitable supply arrangements with additional customers; 12) the ability of all parties to satisfy their performance requirements under existing supply contracts with our two major customers, Boeing and Airbus, and other customers, and the risk of nonpayment by such customers; 13) any adverse impact on Boeing's and Airbus» production of aircraft resulting from cancellations, deferrals, or reduced orders by their customers or from labor disputes, domestic or international hostilities, or acts of terrorism; 14) any adverse impact on the demand for air travel or our operations from the outbreak of diseases or epidemic or pandemic outbreaks; 15) our ability to avoid or recover from cyber-based or other security attacks, information technology failures, or other disruptions; 16) returns on pension plan assets and the impact of future discount rate changes on pension obligations; 17) our ability to borrow additional funds or refinance debt, including our ability to obtain the debt to finance the purchase price for our announced acquisition of Asco on favorable terms or at all; 18) competition from commercial aerospace original equipment manufacturers and other aerostructures suppliers; 19) the effect of governmental laws, such as U.S. export control laws and U.S. and foreign anti-bribery laws such as the Foreign Corrupt Practices Act and the United Kingdom Bribery Act, and environmental laws and agency regulations, both in the U.S. and abroad; 20) the effect of changes in tax law, such as the effect of The Tax Cuts and Jobs Act (the «TCJA») that was enacted on December 22, 2017, and changes to the interpretations of or guidance related thereto, and the Company's ability to accurately calculate and estimate the effect of such changes; 21) any reduction in our credit ratings; 22) our dependence on our suppliers, as well as the cost and availability of raw materials and purchased components; 23) our ability to recruit and retain a critical mass of highly - skilled employees and our relationships with the unions representing many of our employees; 24) spending by the U.S. and other governments on defense; 25) the possibility that our cash flows and our credit facility may not be adequate for our additional capital needs or for payment of interest on, and principal of, our indebtedness; 26) our exposure under our revolving credit facility to higher interest payments should interest rates increase substantially; 27) the effectiveness of any interest rate hedging programs; 28) the effectiveness of our internal control over financial reporting; 29) the outcome or impact of ongoing or future litigation, claims, and regulatory actions; 30) exposure to potential product liability and warranty claims; 31) our ability to effectively assess, manage and integrate acquisitions that we pursue, including our ability to successfully integrate the Asco business and generate synergies and other cost savings; 32) our ability to consummate our announced acquisition of Asco in a timely matter while avoiding any unexpected costs, charges, expenses, adverse changes to business relationships and other business disruptions for ourselves and Asco as a result of the acquisition; 33) our ability to continue selling certain receivables through our supplier financing program; 34) the risks of doing business internationally, including fluctuations in foreign current exchange rates, impositions of tariffs or embargoes, compliance with foreign laws, and domestic and foreign government policies; and 35) our ability to complete the proposed accelerated stock repurchase plan, among other things.
No - one at the Treasury was immediately able to break down the 3 billion pounds committed by Hammond, but obvious calls on the public purse include investment in new customs points and officers, increased staffing to handle migration issues, and new regulatory agencies to do the work currently done at EU level.
The central role of this independent regulatory agency is to protect investors in the financial markets by making sure that publicly traded companies play by the rules.
Expedia, the world's largest online travel agency by bookings, said it expects the deal to close in the first quarter of 2016 subject to regulatory approval.
FCC Chairman Ajit Pai, a Republican appointed by President Donald Trump in January, said the regulatory agency will vote at a Dec. 14 meeting on his plan to rescind the so - called net neutrality rules championed by Democratic former President Barack...
Such a return may occur if the rule is not compatible with the law, if the quality of the agency's analysis is inadequate, if the regulation is not justified by the analysis, if the rule is not consistent with the regulatory principles stated in Executive Order 12866 or with the president's policies and priorities, or if the rule unnecessarily conflicts with other executive branch agency regulations or efforts.
New regulatory stipulations published today, April 3, 2018, by Australia's financial intelligence agency, Australian Transaction Reports and Analysis Centre (AUSTRAC), are based on legislation that was proposed in 2017 and aren't likely to catch any domestically - based digital currency exchanges (DCEs) off guard.
Aquino said that the agency was influenced by recently issued guidelines from the US SEC and regulatory bodies based in Malaysia, Hong Kong, and Thailand.
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.
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.
An industry may seek to capture a regulatory agency in order to entrench incumbent companies in the industry and raise barriers to entry by upstart competitors.
Not only this, but the regulatory agency has also stated that in the country of Columbia, the only medium of exchange that is deemed as legal consists of the country's fiat currency, issued by the Bank of the Republic.
The announcement was made at the beginning of 2017, by the main regulatory agency operating in Columbia, known by the name of Superintendency of Corporations.
This dataset quantifies the number of individual restrictions in an administrative code and determines both which industries are targeted by those regulatory restrictions and which agencies issued the restrictions.
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»);
Compliance risks can be caused by inaccuracies in information presented to regulatory agencies.
«Hard information has been difficult to come by from either the pipeline's operator, TransCanada, or U.S. regulatory agencies, as to when the pipeline might return to full pressure and help to alleviate a backlog of heavy oil barrels that has been accumulating in Alberta against a rising tide of production.
The Australian Transaction Reports and Analysis Centre (AUSTRAC), the country's financial intelligence agency, has approved an application by Blockbid in accordance with the new regulatory powers given to the agency.
«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.»
«NTP has not written a report which «concludes» that 4 - MEI «causes cancer,» nor has NTP otherwise identified 4 - MEI as «causing cancer» in the way that phrase is used by NTP and regulatory agencies with respect to the identification of chemicals as posing a carcinogenic hazard.»
As one of the most highly regulated food industries in the United States, dairy must comply with regulations issued by multiple federal agencies, including the U.S. Food and Drug Administration, the U.S. Department of Agriculture, the U.S. Environmental Protection Agency, the U.S. Department of Homeland Security and the U.S. Department of Commerce, among other state and local regulatory bodies.
This has been confirmed time and again: most recently by Europe's preeminent group of regulatory assessors at the European Medicines Agency Committee for Medicinal Products for Veterinary Use (CVMP), which says in its draft strategy on antimicrobials that: «it is recognized that the biggest driver of AMR in people is the use of antimicrobials in humans or human health.»
«Targeted enforcement and excessive ticketing by regulatory agencies is one of the biggest complaints we hear in our business community.
Review Federal Regulations for Repeal — Vote Passed (240 - 185, 4 Not Voting) The measure would establish a commission to review existing federal regulations and identify those that should be repealed in order to reduce costs on the U.S. economy — including those that should be repealed immediately and those that should be repealed over time through a new regulatory «cut - go» system under which agencies could not issue new rules unless the cost of a new rule was offset by repealing existing rules identified by the commission.
The exemption language in the Governor's bill does not rule out enforcement actions by regulatory agencies (POINT: Examples include denial of licenses to provide services).
«The MSME's were designed to bring government closer to the people by assembling in one place, all the regulatory agencies whose work affects the business experience of small and medium scale businesses,» he said.
Laws are in place to ensure that such outside income does not create a conflict - of - interest for the lawmakers — laws require a combination of requirements that lawmakers recuse themselves of decisions which may directly affect their wealth, prohibit them from using their office for personal gain, and by requiring the disclosure of the sources of outside income in order to ensure that the public — and regulatory agencies — can monitor lawmakers» behavior.
«Clear - cut research priorities could accelerate a great many things, for instance, authorization by regulatory agencies, reimbursement by payers, implementation in clinical practice, and ultimately the development of effective treatments.»
Another is to find a fellowship after your graduate training in an agency or office involved with regulatory affairs; such fellowships are offered by AAAS (the publisher of Science Careers).
In broad terms, a regulatory writer assists in the production of the clinical documentation required by these national regulatory agencies when assessing the safety and efficacy of drugIn broad terms, a regulatory writer assists in the production of the clinical documentation required by these national regulatory agencies when assessing the safety and efficacy of drugin the production of the clinical documentation required by these national regulatory agencies when assessing the safety and efficacy of drugs.
The study, published today in the journal Environmental Research Letters, is based on a new high - resolution model that maps flood risk across the entire continental United States, whereas the existing regulatory flood maps produced by the Federal Emergency Management Agency (FEMA) cover about 60 percent of the continental U.S.
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.
The researchers found in a study that when punitive measures from regulatory agencies were followed by help from business support organizations, companies were more likely to stick to voluntary improvement projects than when these projects were followed by punitive regulatory actions, said Suvrat S. Dhanorkar, assistant professor of supply change management, Penn State.
Or, as you say, we have legal means of recourse — if somebody is harmed by a product, but if the regulatory agency is moving slowly, and if there are efforts in Washington to deprive consumers of legal means — namely, law suits — to go after companies they think have harmed them, then that leaves us in a rough position.
The pathway to market for new products utilizing synthetic biology can be difficult to navigate, posing a challenge for companies in their efforts to commercialize new ideas, while the novelty posed by some of these products can make it difficult for regulatory agencies to evaluate risks, according to a new report from the Synthetic Biology Project.
ABIA, the regulatory body for personal introduction agencies, reported a quadrupling of interest in the past couple of months, while Plentyoffish.com, the only entirely free dating website, registered close to 800,000 users by February this year.
As the head of the regulatory agency for traditional public, charter public, and non-public schools in Louisiana, I think it's important to discuss the facts behind the study, as they raise questions about the conclusions reached by both the researchers and Mr. Bedrick.
Increased regulatory training mandated by state, local and federal governments account for part of the increase in eLearning, and the regulatory agencies» ever - increasing appetite for issuing new regulations guarantees a steady stream of new course development.
Promotes standards harmonization and regulatory cooperation by DOT agencies in order to reduce technical barriers to sales of U.S. goods and services in foreign markets; and
Solicit the views of agencies, associations, and other interested parties on proposed regulatory changes that may be of interest to them (solicitations need not be published in the Federal Register (FR); however, notice of availability of proposed changes to the transit benefit policy may be published in the FR if requested by a member of the Group.
Often in response to requests from individuals or entities, agencies will respond to requests for interpretation of particular regulatory or statutory provisions, sometimes in response to particular factual situations, and generally by letter.
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.
The device recently passed through the database of the regulatory agency carrying the model number A8001, and like the previous Iconia One 8 released back in 2015, it appears that the upcoming slate will fit in the lower - end market segment judging by several hardware characteristics.
In terms of regulatory oversight, Plus500 is regulated by several regulatory agencies.
(B) «Credit repair services organization» does not include: (i) Any person authorized to make loans or extensions of credit under the laws of this state or the United States who is subject to regulation and supervision by this state or the United States; (ii) Any bank or savings and loan institution whose deposits or accounts are eligible for insurance by the Federal Deposit Insurance Corporation or the Savings Association Insurance Fund of the Federal Deposit Insurance Corporation; (iii) Any nonprofit organization exempt from taxation under Section 501 (c)(3) of the Internal Revenue Code of 1986; (iv) Any person licensed as a real estate broker by this state if the person is acting within the course and scope of that license; (v) Any person licensed to practice law in this state if the person renders services within the course and scope of his or her practice as an attorney; (vi) Any broker - dealer registered with the Securities and Exchange Commission or the Commodity Futures Trading Commission if the broker - dealer is acting within the course and scope of those regulatory agencies; or (vii) Any consumer reporting agency as defined in the federal Fair Credit Reporting Act (15 U.S.C. 1681 - 1681t).
Before you sign a contract for either service, check that the company is licensed by calling the appropriate government regulatory agency in your state.
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