Sentences with phrase «in applications for approvals»

The word «harikiri» and the phrase «gut like a fish» are not all that easy to put in an application for approval.

(e) The board shall establish the information needed in an application for the approval of a charter school; provided that the application shall include, but not be limited to, a description of: (i) the mission, purpose, innovation and specialized focus of the proposed charter school; (ii) the innovative methods to be used in the charter school and how they differ from the district or districts from which the charter school is expected to enroll students; (iii) the organization of the school by ages of students or grades to be taught, an estimate of the total enrollment of the school and the district or districts from which the school will enroll students; (iv) the method for admission to the charter school; (v) the educational program, instructional methodology and services to be offered to students, including research on how the proposed program may improve the academic performance of the subgroups listed in the recruitment and retention plan; (vi) the school's capacity to address the particular needs of limited English - proficient students, if applicable, to learn English and learn content matter, including the employment of staff that meets the criteria established by the department; (vii) how the school shall involve parents as partners in the education of their children; (viii) the school governance and bylaws; (ix) a proposed arrangement or contract with an organization that shall manage or operate the school, including any proposed or agreed upon payments to such organization; (x) the financial plan for the operation of the school; (xi) the provision of school facilities and pupil transportation; (xii) the number and qualifications of teachers and administrators to be employed; (xiii) procedures for evaluation and professional development for teachers and administrators; (xiv) a statement of equal educational opportunity which shall state that charter schools shall be open to all students, on a space available basis, and shall not discriminate on the basis of race, color, national origin, creed, sex, gender identity, ethnicity, sexual orientation, mental or physical disability, age, ancestry, athletic performance, special need, proficiency in the English language or academic achievement; (xv) a student recruitment and retention plan, including deliberate, specific strategies the school will use to ensure the provision of equal educational opportunity as stated in clause (xiv) and to attract, enroll and retain a student population that, when compared to students in similar grades in schools from which the charter school is expected to enroll students, contains a comparable academic and demographic profile; and (xvi) plans for disseminating successes and innovations of the charter school to other non-charter public schools.

Airlines have to put in their applications for approval to the FAA, and both Delta and JetBlue have received said approval.

Instead of faxing or submitting additional material to support the loan application, all the information requested is included in the application for an approval decision.

Not exact matches

More than 40,000 companies submitted H - 1B visa applications in fiscal year 2016 and the top 20 sponsors account for 37 % of all visa approvals.

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.

Corporate law firms offer trademark search services for a fee and will ensure that your chosen name isn't taken by businesses in similar industries or in an application that's currently pending approval.

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).

«Precision medicine is already positively affecting providers (for example, by reducing ED visits by 30 % through application of molecular profiling treatment strategy); payers ($ 25 billion expected annual spending on genetic tests by 2021, and 45 % of FDA approvals were geared toward targeted therapies in 2013); and pharma (the pharmacogenomics market is expected to be $ 7.5 billion by 2017).»

You can apply for approval to trade options at Schwab by completing an options trading application here, in a branch or over the phone at 800-435-9050.

LendKey saves borrowers time and money by streamlining that comparison process when it comes to community banks or credit unions... The application and approval process is quick and easy, and will give borrowers the opportunity to view, compare and apply for offers from multiple lenders in real time, making the process even more transparent.

For example, a Supplementary Protection Certificate in Europe may be applied for approval to recover some of the time lost between the patent application filing date and the date of first marketing authorizatiFor example, a Supplementary Protection Certificate in Europe may be applied for approval to recover some of the time lost between the patent application filing date and the date of first marketing authorizatifor approval to recover some of the time lost between the patent application filing date and the date of first marketing authorization.

Omeros Corporation (NASDAQ: OMER) shares are trading higher Tuesday after the commercial - stage biopharma company announced FDA approval for its supplemental new drug application, or sNDA, for OMIDRIA, which expands the indication to include use in pediatric patients, from birth through 17 years...

Maintaining timely approvals for new drugs is vital for drugmakers, since there are dozens of drug approval applications awaiting assessment by the EU regulator in the next few years.

The case is In the Matter of the Application of TransCanada Keystone Pipeline LP for Route Approval of the Keystone XL Pipeline Project, 0p - 0003, Nebraska Public Service Commission (Lincoln).

Roust Corp secures approval for bankruptcy filing An application for bankruptcy in the US by Russian Standard vodka brand owner Roust Corp has been granted.

Meanwhile, Eisai will conduct clinical trials for seeking regulatory approval, and make the applications in Asia.

«As a result, approval for Moon Lake's foreign investment application is the first to be subject to new conditions requiring it to comply with Australian taxation law...» Mr Morrison said, «A breach of these conditions could result in prosecution, fines and potentially divestment of the asset.»

5 February 2018 / In 2016, the International Rice Research Institute (IRRI) filed an application at the Food Standards Australia New Zealand (FSANZ) for the market approval of food derived from so - called Golden Rice (GR2) for import.

I wouldn't worry about residual effects, based on the application in North Carolina, which must have USDA approval for use.

Unconscionable conduct (agrees with NFF that they have not provided protection and support reforms «to provide transparency in the supply chain» and recognise that «certain classes of suppliers... are predisposed to suffering from a special disadvantage...»; misuse of market power (legal framework must «level the balance of market power in negotiations...», «ensure transparency in the transmission of market prices» and «not allow for final market risks to be borne by the primary producer» and provide «transparency of contract processes» - specifically, Canegrowers supports effects test and a process giving ACCC greater power to «regulate anti-competitive behaviour and impose penalties», shifting «the decisions framework from the judicial system to a regulatory system» which would make it more accessible to small producers); collective bargaining (notes limits of Sugar Industry Act (Qld); authorisation and notification approval costly and limited and not a viable alternative - peak bodies should be able to «commence and progress collective bargaining with mills on behalf of their members» and current threshold too restrictive)» competitive neutrality (mixed outcomes - perverse outcomes in the case of natural monopolies - suggest remove «application of competitive neutrality provisions to natural monopoly essential services»)

Changes to competition laws (milk wars discussion and recommendations relating to MMP (introduce effects test), predatory pricing (recommend Minister direct ACCC to investigate Coles for breach of s 46 relating to predatory pricing), unconscionable conduct (suggest it be defined), statutory duty of good faith, unfair contract terms (seeks «recognition of the competitive disadvantage faced by farmers» and extension of unfair contract terms protection to small business), collective bargaining (seeks relaxation of public interest test for boycott approvals in agriculture markets, increase «ability for peak bodies to commence and progress collective bargaining and boycott applications» on behalf of members - and further dairy specific recommendations, ACCC divestiture power (wants ACCC to have similar divestiture powers to Comp Commission in UK - «simpler process of divestiture», ACCC monitoring powers (wants Minister to direct ACCC to use price monitoring powers to «monitor prices, costs and profits relating to the supply of drinking milk») and mandatory code of conduct (wants mandatory code and «Ombudsman with teeth to ensure compliance»)-RRB-.

Metallized Carbon Corporation, a global leader in the manufacture of oil - free, self - lubricating, carbon - graphite materials for severe service lubrication applications, announces that its Metcar Grade M - 58 has received approval from the FDA so that it can be used in food contact applications.

Level III & IV candidates must submit finished application materials with the endorsement fee to the WI - AIMH office no later than six weeks prior to the exam date in order to assure adequate time for review, approval and test scheduling.

In the same vein the CGI has delegated some of his responsibilities such as the approval of certain categories of passport applications to his Deputies and Assistants in order to reduce the work load for the CGI as well as facilitate the processing of passporIn the same vein the CGI has delegated some of his responsibilities such as the approval of certain categories of passport applications to his Deputies and Assistants in order to reduce the work load for the CGI as well as facilitate the processing of passporin order to reduce the work load for the CGI as well as facilitate the processing of passport.

CityLand article on BP Adams recommending the approval of a land use application for the construction of 251 affordable units above a revamped local vendor market and community facility in Flatbush.

In a phone interview from Albany Monday, he said he does not believe the application meets the BSA's criterion for approval.

Section 2 (1) of the Terrorism Act states that «where two or more persons associate for the purpose of, or where an organisation engages in: (a) participating or collaborating in an act of terrorism; (b) promoting, encouraging or exhorting others to commit an act of terrorism; or (c) setting up or pursuing acts of terrorism, the judge in chambers may on an application made by the Attorney General, National Security Adviser or Inspector General of Police on the approval of the President, declare any entity to be a proscribed organisation and the notice should be published in the official gazette».

(4) The independent panel shall report as approved for each judicial position all highly qualified persons who make application to the panel, provided that if the number of highly qualified applicants exceeds three times the number of existing vacancies to be filled in such position (determined as of the time the panel renders its report), the independent panel shall report as approved the most highly qualified applicants in a number equal to three times the number of vacancies to be filled in such position, provided further that if the number of highly qualified applicants is less than three times the number of vacancies to be filled in such position the independent panel shall report as approved the most highly qualified applicants in a number equal to not less than two times the number of such vacancies, provided further that the following categories of applicants who are eligible for reelection or reappointment shall be reported as approved if their performance during their term of office merits continuation in office, and no other applicants shall be reported as approved for their vacancies: (a) a judge or justice completing a full term of office seeking re-election to that office, or (b) an interim Supreme Court justice who has been appointed by the Governor to fill an existing vacancy no later than the previous June 1 after approval of the Governor's screening panel, who has been confirmed by the State Senate and has assumed office no later than the date the panel renders its report, and who otherwise would not be required to make application to the independent screening panel pursuant to the provisions of sub-paragraph (3).

The Type Approval Regulation, called «Regulation for the approval and market surveillance of two or three - wheel vehicles and quadricycles», is aimed primarily at improving and tidying up the type approval process but in its application has raised many fears amongst British motorcyclists and it these that the BMF's Government Relations Executive, Chris Hodder, has clarified wiApproval Regulation, called «Regulation for the approval and market surveillance of two or three - wheel vehicles and quadricycles», is aimed primarily at improving and tidying up the type approval process but in its application has raised many fears amongst British motorcyclists and it these that the BMF's Government Relations Executive, Chris Hodder, has clarified wiapproval and market surveillance of two or three - wheel vehicles and quadricycles», is aimed primarily at improving and tidying up the type approval process but in its application has raised many fears amongst British motorcyclists and it these that the BMF's Government Relations Executive, Chris Hodder, has clarified wiapproval process but in its application has raised many fears amongst British motorcyclists and it these that the BMF's Government Relations Executive, Chris Hodder, has clarified with MEPs.

The CP said, «Henceforth, all new application / request in respect of the services of police mobile men; Special Protection Unit; Counter Terrorism Squad; and Conventional Police, must be processed and submitted to the Office of the Commissioner of Police, Anambra State Police Command Headquarters, Awka, who will forward all applications to the Inspector - General of Police for approval.»

The ruling by the commission that oversees the Nuclear Regulatory Commission reversed the Atomic Licensing Safety Board's approval of a prior analysis used in Westchester - based Indian Point's 2007 application for relicensing.

4.2.5 Submit articles and excerpts from the Licensed Materials to regulatory agencies in connection with applications for drug and product approval provided that such uses do not amount to commercial redistribution for direct profit; provided each article or excerpt from the Licensed Materials contains a credit line noting the original appearance of the article in its appropriate journal; provided any portion of the Licensed Materials used for these purposes looks identical to the original material; and provided such use does not present any material from the Licensed Materials in any manner that implies that Publisher endorses Licensee or any of the Licensee's products or services;

A spokesperson for American Cyanamid says that the company may file new applications for EPA approval in the future and that the withdrawal should not be seen as an admission that the product has toxic effects.

Applications due for final approval or renewal in September or October should be given expedited treatment, she said.

The FDA had already rejected Arena's first application for approval of Belviq in September 2010 because the compound seemed to produce tumours in rats and because the company could not statistically rule out an increase in the risk of heart - valve problems.

«At least in the scientific community, I sense more support for basic - research applications,» says Lanner, who gained approval for his experiments last June.

Pending approval through an Investigative New Drug Application, the aerosolized form of the vaccine will be evaluated for replication, safety and immunity development in a study in adults.

(2) that prior to the submission of an application for PHS support for a research project on which the Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS - supported research, Respondent shall ensure that a plan for supervision of Respondent's duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agreed that he shall not participate in any PHS - supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan;

Other responsibilities include general lab management duties, scheduling and planning assistance, budget monitoring and purchase orders approval, providing technical assistance to students and other laboratory personnel, obtaining approvals required for environmental safety, animal use, and stem cell use (e.g., laboratory clearance, IACUC, IRB, SCRO, and BUA), and assisting in the assembly of materials for grant and fellowship applications.

At the same time, we will also issue a compliance policy that, with the exception of outliers potentially harming public health in a significant way right now, will give current product developers a very reasonable period of time to interact with the FDA in order to determine if they need to submit an application for marketing authorization and to come into the agency and work on a path toward approval.

These observations suggest that human subject concerns are not being adequately addressed in the preparation of clinical grant applications, and this problem may have been augmented by rescinding the requirement for IRB approval prior to NIH peer review.

The registry also lists those lines in «draft status,» whose owners have begun applying to the agency for approval but not yet completed their applications.

In response to mounting concerns about the adequacy of protection of research participants, at a regulatory level, increasing attention is being focused on safety and confidentiality of human subjects participating in research protocols.26 - 28 Beginning with applications submitted for the January 2001 council round, institutional review board (IRB) approval is no longer required prior to NIH peer review; previous NIH policy had been that IRB approval was required at the time of submissioIn response to mounting concerns about the adequacy of protection of research participants, at a regulatory level, increasing attention is being focused on safety and confidentiality of human subjects participating in research protocols.26 - 28 Beginning with applications submitted for the January 2001 council round, institutional review board (IRB) approval is no longer required prior to NIH peer review; previous NIH policy had been that IRB approval was required at the time of submissioin research protocols.26 - 28 Beginning with applications submitted for the January 2001 council round, institutional review board (IRB) approval is no longer required prior to NIH peer review; previous NIH policy had been that IRB approval was required at the time of submission.

We encourage each of our applicants to share this contract as early as possible in the application process with the technology transfer office of the applicant's university or research institute, so that the application and approval process can proceed smoothly for all.

The access and services include applications for regulatory and / or ethical approval (by European and Dutch law), optimisation of study design and the summary of results in a study report.

In 2003, the FDA approved memantine for moderate - to - severe Alzheimer's disease, but two years later the agency rejected an application from the manufacturer, Forest Laboratories, to expand the approval to mild Alzheimer's.

Once the Permanent Phase application process opens in June 2018, health and wellness coach training and education programs may apply for ICHWC program approval.

The European Medicines Agency found the drug to be so unsafe that they rejected approval of the drug, causing the manufacturer of Belviq, Arena Pharmaceuticals, to withdraw their application for the drug's availability and use in Europe.

Clinical trials have shown safety and effectiveness in easing RLS symptoms in the course of 12 weeks, and the FDA recently asked Solzira's manufacturer to reorganize and resubmit its application for drug approval consideration.