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 ?
Shire Obtains FDA Approval for VPRIV for Treating Type 1
Following another three years of review and upon receiving most, if not all of its relevant approvals by 2001, the developers were required to go before the Town Board one last lime for supposedly a purely technical or ministerial cluster approval prior to receiving its final approval.
Trial results affect the drug's approval and marketing, and can also have an immediate influence on the company's stock price.
Nasdaq SmallCap: BGMR) has received approval from the Intercantonal Office for the Control of Medicine (IKS) in Switzerland to utilize IV bags as a drug delivery system for Metronidazole, an antibiotic used in the treatment of serious infections caused by anaerobic bacteria.
The MDMA, by contrast, would relocate the center as an independent part of the Public Health Service and completely privatize device approvals using independent outside reviewers.
This is evidenced by the increased scrutiny with which the FDA appraises accelerated approval applications, particularly in light of the 2005 withdrawal of AstraZenecas Iressa.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward looking statements, including without limitation, statements regarding Bentley's new product approvals in Europe and the size of the markets reported for such products.
We continue to work aggressively toward obtaining approvals from the remaining commissions.
In addition, because of the pending approval of the products with the FDA, the Company's distributors who have purchased product during 2006 have also suspended their sale of the products, and thus the Company has not collected on the outstanding receivables from these distributors.
The Company noted that it continues to have tentative approval for its 5 mg and 10 mg versions of generic Ditropan XL.
NitroMist([TM]) is NovaDel's first product approval utilizing its proprietary oral spray technology.
The Humanitarian Device Exemption (HDE) approval of the AbioCor signifies that no comparable alternative therapy exists for patients facing imminent death without the technology, and that it has proven to be safe and have probable benefit for patients.