approval


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approval

An affirmative decision by an institutional review board (IRB) that the protocol for a clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, guidelines for good clinical practice (GCP) and applicable regulatory requirements.
References in periodicals archive ?
In addition, four approvals were delegated to Qena and Beni Suef, three approvals for Kafr El-Sheikh and two for Port Said and one approval each for Suez and Matruh.
An IDA spokesman said it was now likely the bond application would be granted full approval "in the not too distant future.
Here, the starting off point is a recent article by Nickelsburg and Norporth (2000), who employ quarterly foreign and economic policy approval series across a twenty-year period to investigate the comparative impacts of the two policy areas in the public mind on evaluations of the president.
Most recent polling has the President's approval ratings dropping into the 60 percent range for the first time since before September 11.
2002-37, if a C corporation fulfills certain requirements, it will be presumed to have established a business purpose necessary to receive automatic approval to change its annual accounting period under Sec.
Today, some voices question whether accelerated approval is necessary any more, since there are already 17 HIV antiviral drugs on the market.
Trial results affect the drug's approval and marketing, and can also have an immediate influence on the company's stock price.
The company also filed for approval from the IKS for the formulation of Nitroglycerin IV bags to be used in treating patients with heart disease.
The average time it takes a drug company to develop and gain approval for a new drug has almost doubled over the past 30 years - from 8.
The Blue Cross and Blue Shield Association also has coverage criteria that extend beyond FDA approval.
PROOF-it-ONLINE's Team Track feature, which provides a method to post proofs online for various intermediaries who can then route the proofs on to their clients for final review and approval, was a key component in the selection process.
Town Board members had in fact, on the record, told representatives of the developer that the Comprehensive Plan being discussed at the time would in no way affect them, and that approval for the project was an independent action that could be expected at its next meeting.