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 ?
Orphan Europe Receives FDA Approval for Carbaglu 52
This has been one of the most onerous approvals processes this firm has ever experienced, but we trusted the Town and were determined to work with them at every juncture to create the type of high quality mixed use development, which they encouraged us to build on the site," explained Harvey Schulweis, the managing partner of Putnam Seabury.
We can assess the causal relationship between foreign (and economic) approval and general presidential approval by regressing current values of general approval on lagged values of general approval and lagged values of foreign (economic) policy approval and also by regressing current values of foreign (economic) approval on lagged values of itself and lagged values of general approval.
But presidential approval also became a surrogate measure of national unity and patriotism.
2002-38 lays out the automatic approval procedures for partnerships, S corporations, electing S corporations and personal service corporations (PSCs) to change annual accounting periods.
Rhetorically, it sounded much like today's accelerated approval, but HIV public policy groups were split on the proposal, with some prominent organizations arguing against it as a "sellout to the pharmaceutical industry.
In order to gain FDA approval for a drug, a company or researcher submits a package of data from a series of clinical trials.
In this regard, Bigmar plans to apply for ANDA approvals in the United States as well as various approvals from European regulatory authorities for the above-mentioned generic oncology drugs in IV bags during the first half of 2000.
manufacturers from exporting devices that are approved for use in other countries but not yet approved here, and allow "breakthrough" drugs to be approved after one set of clinical trials, cutting approval times for those drugs by years rather than months.
Two different approval processes--the premarket approval (PMA) and the premarket notification of 501(K) process-are available to Class III devices.
One drawback of expeditious approval (as opposed to automatic approval) is that a corporation requesting expeditious approval must conform to Rev.
Because of this determination, the Audit Committee, pursuant to an exception provided in the exchange's Shareholder Approval Policy for this kind of situation, expressly approved not seeking the stockholder approval that would otherwise have been required under the policy.