Sentences with phrase «approval of the application in»

Previous approval of an application in no way guarantees approval of a re-submitted application.

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.

Feb 14 - Federal Communications Commission Chairman Ajit Pai on Wednesday proposed the approval of an application by Elon Musk's SpaceX to provide broadband services using satellites in the United States and worldwide.

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).»

Our upfront honest approach and fast turn around results in a higher number of application approvals.

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 authorization.

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).

«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.

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-.

Free Label Approval Service: Alcohol and Tobacco Tax and Trade Bureau of the U.S. Department of the Treasury (TTB - formerly known as the Alcohol, Tobacco and Firearms [ATF] Bureau) wine label applications are meticulously reviewed in our Washington, D.C., office.

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.

Of the 125 applications to the Illinois Department of Conservation, 32 received money in this fiscal year and 37 in the next fiscal year, contingent on the General Assembly «s approvaOf the 125 applications to the Illinois Department of Conservation, 32 received money in this fiscal year and 37 in the next fiscal year, contingent on the General Assembly «s approvaof Conservation, 32 received money in this fiscal year and 37 in the next fiscal year, contingent on the General Assembly «s approval.

Upon approval of your application, SNA will send you a verification letter to confirm you earned your SNA Certificate in School Nutrition.

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.

«We are gratified by the City Planning Commission's thoughful and balanced approach in the consideration and approval of Jamestown's application to expand Chelsea Market,» said Michael Phillips, Jamestown's Chief Operating Officer, in a statement.

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».

Chief among them is the fact that while any zoning application ultimately needs the approval of the City Council's 51 members — 42 of whom voted in favor of Mandatory Inclusionary Housing — when it comes to individual projects, the council's long - standing tradition is to defer to the local council member.

(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.

Mr. Speaker, Section 17 (1) of the Act in issue provides: «Subject to this section, the Minister may on an application and with the approval of the President grant the status of right of abode to any of the following persons: a) a Ghanaian by birth, adoption, registration or naturalization, within the meaning of the Citizenship Act who by reason of his acquisition of a foreign nationality has lost his Ghanaian citizenship; and b) a person of African descent in the Diaspora.

The new policy received unanimous approval by the agency's board at its May 20 session and will be forwarded to all IDAs in Erie County with the goal of uniform application and compliance.

QUEENS, NY — Borough President Melinda Katz, former Chair of the City Council Land Use Committee, stated the following in response to questions about the Committee's approval this afternoon of the Astoria Cove project's rezoning application:

While awaiting approval of their license application, military spouses may receive a temporary license to practice their profession in New York.

In November, Community Board 10 recommended approval of the application, on the condition that the developer reduce the project's height to eight or nine stories.

DEC anticipates site work to begin in February 2018 pending approval of the Adirondack Park Agency permit application, which the agency has deemed complete.

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;

«We are encouraging people to come in and to get to the place where they are ready to do their pivotal studies and to submit a premarket approval application,» says Stayce Beck, chief of the FDA's Diabetes Diagnostic Devices Branch.

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.

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.

Our streamlined application process has cut approval time in half, with accreditation evaluation typically completed within 60 days of image submission.

A report of the findings, published Oct. 16 in the Journal of Investigative Dermatology, marks efforts to seek approval from the U.S. Food and Drug Administration (FDA) to use the gel application in treatment - resistant skin wounds among diabetics and others, particularly older 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.

The use of autologous cell products in «non-homologous» applications will require full FDA 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 panel recommended approval of two of four «modules» in the application, totaling $ 16.6 million.

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.

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.