Sentences with phrase «decision on the approval»

However, the FDA should hand down its decision on approval for topical pain drug ZTlido by Feb. 28, 2018.

The FDA is expected to make a final decision on approval by Oct. 3.

Depending on their income, the lenders make a decision on the approval of their loan.

The Safe Harbor Term Life Express policy is a simplified issue product that gives an immediate decision on approval for same day coverage.

Not exact matches

Compared with standard commercial loan products, the underwriting examines cash flow closely as a basis for approvals and decisions on loan rates.

At a small business, approval might be granted after an employee sends a short email message because managers might make those decisions on the spur of the moment.

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

Wesfarmers - owned Coles has received approval from the Australian Competition and Consumer Commission for its proposed acquisition of three Metcash - owned Progressive Supa IGA supermarkets, but is yet to make a decision on the fourth.

• The prospect understands the full impact your solution could have on his business • The prospect has decision - making authority • You know and understand the approval process • The prospect understands your pricing

Holmes did confirm that the company, only «as of a few weeks ago,» is using only one «finger prick» blood test commercially, but says that was her own decision, based on her desire to get FDA approval for its process.»

The other big announcement was Employment Minister Jason Kenney's decision to place a moratorium on new approvals for restaurants to hire temporary foreign workers, in response to a myriad of complaints about abuses under the federal program.

Good leadership puts a priority on making the right (or at least best possible) decisions and accepting that they might not make everyone happy, much less win everyone's approval.

Reviews are also non-binding on publication — it's peer - review, not peer - approval, and the final decision to publish, as with almost any peer - reviewed article, rests with the editor / co - editor / publisher.

WASHINGTON, April 30 The judge who will decide if AT&T will be allowed to buy movie and TV show maker Time Warner indicated on Monday that he could be considering a decision that wasn't a clear approval or blocking of the $ 85 billion deal.

WASHINGTON (Reuters)- The judge who will decide if AT&T will be allowed to buy movie and TV show maker Time Warner indicated on Monday that he could be considering a decision that wasn't a clear approval or blocking of the $ 85 billion deal.

The deadline for approval or disapproval from the SEC has not been specified, although sources suggest that a decision could be made on or around August or October of 2017.

«While the consensus view is that FDA approval will occur, the impact such a decision will have on current DEA scheduling remains in question,» Karnes said.

The judge who will decide if AT&T will be allowed to buy movie and TV show maker Time Warner indicated on Monday that he could be considering a decision that wasn't a clear approval or blocking of the $ 85 billion deal.

On his decision to use executive power to ban bump stocks without Congress's approval: «I would recommend him against that,» Rep. Joe Barton (R - TX) said.

However, given the delays, the Kidman Board has postponed any decision on the bids until there is finalisation on the statutory and commercial approvals.»

A decision on the sale of Australia's largest private landholder S.Kidman & Co has been delayed due to government regulatory approvals.

Still, its offer is conditional on approval from the Australian Competition Tribunal, which is set to make a decision by February 28.

Murray Goulburn's bid for Warrnambool was conditional on approval by the Australian Competition Tribunal, which was due to make a decision on February 4.

Murray Goulburn had offered $ 9.50 cash per share, or $ 533 million, but that hinged on acquiring at least 50 per cent of WCB and gaining approval from the Australian Competition Tribunal, which is set to make a decision by February 28.

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»)

As he looks forward to the second chapter of his story with Chelsea, Essien has seemingly given his seal of approval on the move, although there are many who have questioned the sense in the transfer and are surprised by Antonio Conte's decision.

However, the de Blasio administration is entitled to cancel the City's contract with QDG, and to rescind the sale of two acres of Willets Point property already transferred to QDG for $ 1, due to the recent decision of the New York State Court of Appeals which found that QDG's proposed «Willets West» mega-mall on parkland located west of Citi Field stadium can not proceed as it lacks legislative approval.

That figure rose slightly when members were asked if they supported Mr Clegg's decisions to enter into discussions with the Conservatives on that basis, with 90 % expressing their approval.

«To date, the government has chosen to opt in on every occasion it has had to make such a decision and has not required parliament's approval.

He did not give further explanation for his latest decision but said, «I do recognize that these are facilities that are conventionally extended to Presidents that leave office and I am also mindful of the approval by the Parliament of the Republic of Ghana on Wednesday, 4th January, 2017 at its Twenty - Second Sitting of the Third Meeting of the Fourth Session.»

The final decisions and recommendations from the Committee would be passed on to the President and Commander - In - Chief for approval.

It was also alleged that Osinbajo travelled to London, where Buhari is currently on medical vacation, to get approvals for some decisions.

«Within the armed forces we have a set of procedures that are open, known for how you make decisions about when to use deadly force or not, levels of approval degrees of proof and so on and they are things that can be and should be openly put out.

The department has been sitting on a number of key decisions as well, including approvals of natural gas pipelines, an underground gas storage facility in the Finger Lakes and crude oil heating facility for the Port of Albany.

The OYC further frowned on the appointment of a Special Adviser on Media and Publicity to the President General, Ohanaeze Ndigbo, by Nwodo, as well as the appointment of a Director of Administration, which they said were done without the approval of the Ime - Obi, the organisation's highest decision making organ.

Cuomo's counsel, Alphonso David, said in the letter on May 2nd to top SUNY officials that «all decisions» made in the future by SUNY Poly and the SUNY Research Foundation regarding the Buffalo Billion on Nano programs «shall be subject to review and approval» by Cuomo's own specially appointed investigator, Bart Schwartz.

«The decision to deny the approvals necessary for the construction of the Constitution Pipeline will have a direct and immediate negative impact on our state's economy.»

Donohue made it clear this decision is a «direct result» of the deal struck last week by Gov. Andrew Cuomo and legislative leaders, in which organized labor believes the governor «traded» his approval on the LATFOR redistricting plans for lawmakers» support of pension reform.

His wife's approval or disapproval of a job candidate, Mr. de Blasio said, weighs heavily on his hiring decisions.

However, based on their decision earlier this week, they've said they'll deny land - use approvals because of that PILOT.

When the County Executive, Comptroller, County Clerk, Sheriff, District Attorney, or a department head, needs legislative approval for some action which is required for the proper functioning of county government, be it the approval of the annual budget or the change in the title of a county job, a letter is sent to the legislature, often accompanied by additional information which can be used by the legislators in making a decision on the matter.

Therefore, «spending decisions shall not be treated as dependent on the approval [from the committees].»

«Although FDA approval is critically important for introducing a new screening test or algorithm, providers ultimately rely on guidance or guidelines to help them make the best decisions for their patients and want to understand advantages, disadvantages and unknowns associated with a new screening approach,» said Huh, who is a senior scientist for the UAB Comprehensive Cancer Center, Director of the UAB Division of Gynecologic Oncology, and is also a board member for both the American Society for Colposcopy and Cervical Pathology and the Society of Gynecologic Oncology.

The FDA traditionally has taken a product - specific approach to drug approval decisions by focusing on the data generated and submitted by a drug's manufacturer and balancing the benefits against the known risks to the individual patient.

Scientists poured scorn on the decision, contending it puts patients at risk and undermines the authority of the Brazilian Health Surveillance Agency (the equivalent of the U.S. Food and Drug Administration) to regulate research and approval of new drugs based on internationally accepted safety and efficacy protocols.

Further on he warns that in the oversight committee's next funding round in July, «negative decisions» about peer - reviewed grants awaiting the board's final approval «would have a fatal impact on CPRIT's peer review system» and would «be extremely harmful to the research community's view of science in Texas, and thus on the ability to recruit scientists to the state.»

Paired with a mentor who aimed to give him a broad look at the intersection of health services research and medicine, Neiman worked on a paper about total knee replacement, a project surveying part of the FDA's drug approval process, and another study about shared decision - making between patients and doctors.

An approval decision for the Kite CAR - T is expected on Nov. 29.

The Federal Aviation Administration's Research Development and Human Factors Laboratory in Atlantic City, staffed by a rock - star group of scientists, had given CTs their sole nod of approval — a decision that meant spending $ 1 billion on those machines versus $ 150 million for the ATs.

It calls for the hospital to be more independent from KI, especially in hiring decisions, and recommends additional training for staff on regulations surrounding ethics approval and new medical products.