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As in drug trials, the use of PROs in device evaluation has several methodological challenges, ranging from general concerns about interpretation, to more specific issues related to study design and regulatory approval (use of PROs as primary end points, incorporation in labeling, and product promotion).
Ethical approval: Use of the CiPCA database for anonymised patient research was granted by the North Staffordshire Research Ethics Committee.
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Making such distinctions between the post-approval use of biosimilars might be needed to describe the different possibilities.
But the city never sought legislative approval for use of the park.
In a telephone conference call, the F.D.A. gave emergency approval for use of the untested drug.
Based on these results, an advisory committee to the F.D.A. recommended rescinding approval for use of Avastin in breast cancer.
The likely approval and use of herbicide-resistant crops in the U.S. engineered to survive applications of multiple herbicides adds tricky new dimensions to herbicide-risk assessments.
Arizona went all the way to the U.S. Supreme Court to gain approval of use of the British drug.
Mexico is one of 20 countries in Latin America and Asia where Sanofi is currently seeking regulatory approval for use of the vaccine.
Martinez's second, active lawsuit is intended to make Chicago police explain the process by which they secure approval for use of the devices.
Ethical approval for use of this material was obtained from the Compton Human Subjects Committee.
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