Sentences with phrase «with federal approval»

As a result of such concerns, some states, with federal approval, have pushed back the dates for attaching consequences to the reviews.

Not exact matches

In 2011, Restoration Robotics got approval from the U.S. Federal Drug Administration to begin commercial operations with its Artas System, which uses digital imaging and a robotic arm to help with the hair transplant procedure.
The September decision by the Obama administration to delay final approval for the Dakota Access Pipeline was intended to give federal officials more time to consult with Native American tribes that have faced dispossession from lands for decades.
It may seem auspicious, coming as it does while the federal government ponders approval of China National Offshore Oil Co.'s $ 15 - billion purchase of Calgary - based Nexen, but the new investment agreement with China that is soon to be ratified in Parliament was actually 18 years in the making.
The city argues in a news release that the company should be required to comply with all municipal bylaws, despite its argument they were unconstitutional because they conflicted with approval from the federal government and the National Energy Board Act.
It requires states and local governments with a history of racial and ethnic discrimination, mainly in the South, to get advance approval either from the Justice Department or the federal court in Washington before making any changes that affect elections.
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).
In October 2016, a month before the federal approval, Suncor again met with provincial government officials.
In fact, according to the Federal Reserve Bank, business owners spend on average 33 hours searching and applying for credit from traditional sources — with no guarantee of approval.
It's hard to reconcile statement that the approvals are in hand with the fact that no provincial permits have been granted and significant federal approval remain.
When the federal government was unable to get approval from the provincial governments for this proposal, it continued with Stage Two of Tax Reform and replaced the manufacturers» sales tax with the Goods and Services Tax (GST).
The separation is subject to certain conditions, including, among others, obtaining final approval from HP Co.'s board of directors, receipt of a private letter ruling from the IRS and one or more opinions with respect to certain U.S. federal income tax matters relating to the separation and the SEC declaring the effectiveness of the registration statement of which this information statement forms a part.
The separation is subject to certain conditions, including, among others, obtaining final approval from Parent's board of directors, receipt of a private letter ruling from the IRS and one or more opinions with respect to certain U.S. federal income tax matters relating to the separation and the SEC declaring the effectiveness of the registration statement of which this information statement forms a part.
Various permits are also being advanced with state and federal agencies — such as water discharge, wetlands, air quality, water use and fish habitat permits and other approvals that will give them right - of - way access.
US Airways (NYSE: LCC) said on Wednesday that it wants to boost its chances of completing a merger with AMR Corp by seeking the approval of federal antitrust regulators.
Label approval from the federal Alcohol and Tobacco Tax and Trade Bureau can take up to 90 days, with state approvals usually requiring approximately a month.
The legislation approval furthers California and federal law that already requires employers to make their best efforts to provide nursing mothers with lactation breaks.
Settlement final: The Federal Trade Commission gave final approval of an agreement settling charges against Abbott Laboratories that it conspired with others not to advertise its infant formula through the mass media.
RACHEL JACKSON: Yes, actually I found out about the federal bill and they knew about Mikael's bill on the assembly floor and so I drafted a mirror bill and gave it to senator Kennedy, New York State Senator Kennedy and he really ran with it and introduced it to the senate and so together where Tim and Kennedy have been working with him to get approval for that, so I was lobbying in Albany and that's where I got to meet Mikael and spoke with a lot of the assembly members, a lot of the senators and there was real overwhelming support for it.
For a good example of how the virtual can combine with the real to yield results, see Food and Water Watch «s campaign last year to get federal approval for schools to buy hormone - free milk through the National School Lunch Program.
Both officials need a strong working relationship with the federal government and with each suffering from low job approval ratings, they should get back to working on behalf of New York's citizens, not their own political ambitions.»
«Our next steps include finalising commercial arrangements for gas supply, securing gas pipeline financing support with the Federal Government, obtaining environmental and land access approvals, and developing detailed refinery conversion plans,» Mr Biswas said.
The US constitution does not allow US states to sign treaties with foreign countries without federal approval, for instance.
On the eve of the Federal Circuit Court's approval of Congressional district lines that were seen to be extraordinarily favorable to Ackerman, and with the primary - free backing of the Democratic Party virtually assured, Ackerman has informed his family, staff, friends and party leaders that he will not seek a 16th term of office.
The state would drop that lawsuit as part of the settlement agreement with the Oneidas, and that dismissal would require the approval of the federal judge in the trust land case.
Presidency considers palliatives The Federal Government may go ahead with the withdrawal of fuel subsidy without the National Assembly's approval, The Nation learnt at the...
He said the new package of bills, which requires approval from the state Legislature, will align New York's laws with federal ones.
Gov. Andrew Cuomo in an interview on Sunday called his effort to gain more «flexibility» over the budget after its approval a «major sticking point» with lawmakers, but a necessary move given the potential for federal actions that could negatively impact the state.
The report found federal officials raised issues with the details loan in a letter to EFC board members prior to approval, but those questions and reservations were dismissed.
The last thing that anyone would want is legal complications to arise from importing marijuana products over state lines without federal approval, or for unnecessary delays with the implementation of the current program to come as a result of layering a separate process on top of it.»
The lawmaker, who represents Dutsin - ma / Kurfi Federal Constituency of Katsina State noted that, «I also think that the NNPC GMD was right when he said that there was no law requiring him to review or discuss with the minister of state or the NNPC board, matters relating to the approval of contracts.
«It is equally significant to state that the current recruitment of additional Ten Thousand (10,000) Police Personnel into the Force by the Federal Government of Nigeria and the request by the Inspector General of Police to Government for approval of the recruitment of Thirty One Thousand (31,000) Police Personnel yearly for a period of 5 years will definitely increase the strength of the Force to meet up with the UN ratio of One (1) Policeman to Four Hundred (400) citizens.
Cuomo signed the measure into law but noted in his approval memo that legislators would need to amend the law to clarify that it does not conflict with federal law.
«It's beyond us why Governor Christie would want to spend so much time with Andrew Cuomo, who is under investigation by federal prosecutors, got caught cheating on his property taxes and has an approval rating that plummeted to 42 percent,» said Astorino spokeswoman Jessica Proud.
(EFCC Press Release) The trial of a cousin to former President Goodluck Jonathan, Azibaola Robert, his wife, Stella and their company, One Plus Holdings, continued before Justice Nnamdi Dimgba of the Federal High Court sitting in Maitama, Abuja on Wednesday, June 21, 2017 with a prosecution witness, David Nkpe, telling the court how some individuals and companies were alleged to have received payment from the Office of the National Security Adviser, ONSA, without contract or approvals.
Blair Horner, with the American Cancer Society, says approval of the health exchanges will trigger appropriations of federal money, so it makes sense to include them as part of the budget.
«The FERC staff concludes that approval of the proposed Project, with appropriate mitigating measures, would not constitute a major federal action significantly affecting the quality of the human environment,» federal regulators said in a statement.
«The Vice President reiterated Federal Government's policy that NNPC and other agencies must present budget for approval before spending in line with TSA.»
Please visit the following website for the status of federal reviews, permits and approvals associated with the project:
Candidates and Campaigns Committee recruits suitable candidates for county elective office, screen candidates for approval by the County Committee, provide information and logistical support to candidates for village, town and county elective office, and assist in their campaigns within the county; this group shall also maintain a County Committee liaison with the county board of elections, provide advice on requirements of the Election Law, and prepare petitions for Democratic candidates; in addition it will maintain communications with the state and national Democratic Parties and develop and support candidates for state and federal office in concert with the state and national parties.
Administration officials said the state is having positive talks with federal officials and is confident about winning approval for the plan this year.
Attorney General George Jepsen cautioned Tuesday that a tribal casino in East Windsor should not open without formal approval by federal regulators of amendments to existing slot machine revenue - sharing agreements with the state.
With this approval in federal court, the final hurdle has been cleared.
«With veteran and former federal prosecutor Mikie Sherrill's strong candidacy, and the abysmal approval ratings of Speaker Ryan's Republican Congress, Democrats are confident that this seat will turn blue next November.»
The Heritage Foundation issued a report saying that the UN land swap with the city designed to connect the East Side's waterfront esplanade is a federal issue, and needs the approval of Congress.
Because NYCHA is a federal agency, they need only federal approval to sell land or partner with developers.
This week, the Massachusetts project cleared a major hurdle with approval of a power purchasing agreement, but it still must find $ 2 billion worth of financing through a mix of investors and federal incentives to become the nation's first offshore wind farm (ClimateWire, Nov. 23).
Researchers estimate that as many as 2.1 million patients with mild cognitive impairment could develop Alzheimer's dementia over a two - decade period while waiting for evaluation and treatment resources after approval of an Alzheimer's disease - modifying therapy by the federal Food and Drug Administration.
In March, researchers, in collaboration with the pharmaceutical company Ultragenyx, completed the first part of a Phase III clinical trial in adults with XLH — the final test of a drug before federal approval.
Fast - forward from that first lightbulb moment with the video through a couple of years refining the idea, patent approval, and the formation of Marine Desalination Systems in 1999 to the procurement of federal funding in 2001, and Max is in St. Petersburg, Florida, with a lab in a refurbished 1927 art deco building where Sealtest once made cherry - vanilla ice cream.
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