Cleveland Clinic cardiologist Steven Nissen, an early critic of Zetia, says the Food and Drug Administration should have demanded Merck begin a giant study comparing Zetia with placebo immediately upon approval.
Because BioMarin's drugs serve small patient populations, each drug is granted orphan status upon approval, which means exclusivity for seven years in the U.S. Revenues from one drug should eventually throw off enough cash to fund further drug development, figures Yun.
Now there is a powerful in-between option called REMS. This can be anything from forcing a drug company to do a few extra safety studies upon approval, to creating prescribing restrictions so tight that few patients are likely to bother with the hassle.
Whether the EchoStar deal sticks depends entirely upon regulatory approval for its Hughes merger.
Any purchase will be conditional upon the approval of the Football League and the Football Association, it was announced.
Woch had something akin to oral authorization to enter sell orders conditioned upon FDA approval, but those orders constituted a grant to the stockbroker of discretion, which needed to be in writing and approved by his firm (which was not what transpired).
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Merely having the personal exception for the blind, dependent upon a triennial approval from the Librarian of Congress, does not solve the problem.
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Second, upon gaining the approval of the SBA, the U.S. Department of State (if the person is outside the country) or U.S. Citizenship and Immigration Services would conduct the necessary background and security checks to ensure admissibility.
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Effective July 1, 2011, any new source of greenhouse gas emissions that exceeds 100, 000 tons of CO2 per year or plant modification adding 75, 000 tons annually, will be subject to permit approval based upon undefined case-by-case "best available control technology" assessments.
"Upon the court's approval of the order, the council intends to seek submissions from the parties before finalising the next steps in relation to the northern part of the site, " it added.
One can also expect any such approval to be conditioned upon the explicit permission of judicial enforcement of said rules.
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South Korea's current nuclear pact with Washington expires in 2014, but U.S. and South Korean officials said the terms of a new deal would need to be agreed upon by June in order to gain congressional approval by year-end.
Thus, barring any unforeseen catastrophic circumstances that cannot be anticipated at loan approval, a consumer can be relied upon to repay their mortgage back on time.
The deal, which is expected to be completed early next year, is conditional upon successful completion of a bond offer, European Union approval and Kansas State Commission consent.
Because most small-molecule drugs can be manufactured with easily replicable chemical processes that lead to a largely reproducible drug formulation, the clinical trial data that supported approval of the original version can be relied upon for the generic versions.
Her science background helps her predict whether or not drugs will win approval and she's able to judge the risk reward profile based upon the current midstage clinical study.
Its latest winning strategy is the success of its coffee, which has won approval from Consumer Reports magazine who rated McDonald's coffee higher than Starbucks based upon both taste and price.
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