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.