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Indeed, they suggested that basing the appraisal on manufacturers' submissions might lead to delays if there had to be an iterative process of requesting further data or analyses.
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The research analyst maintained a "neutral" rating on the stock and predicted that the FDA would likely request further data on Fibrillex from Neurochem.
If sufficient data were not reported in the published article or online supplementary material provided, the corresponding author was contacted to request further data.
These data were sufficient for approval from the European Medicines Agency (the Epigenomics Epi proColon), but an FDA advisory panel split 5-4 on the matter in early 2014, and the FDA itself has requested further data on screening compliance before granting approval [ 101].
Editor—We would like to thank Ormonde and colleagues, who requested further data on our study regarding the time course of haemostatic effects of fibrinogen concentration in patients undergoing aortic surgery with cardiopulmonary bypass (CPB), for their interest in our work.
Not requesting further information from the authors in cases where data was missing is one weakness of our overview.
In case of missing clinical data or unsuitable data presentation the corresponding authors were contacted via electronic mail requesting further information, [ 59, 60].
When we were uncertain about eligibility or needed additional data on endpoints, we contacted the corresponding author to request further information.
To that end, the government apparently also is requesting further access to data being passed through networks like Viber and Skype.
Their solution is called DxtER (pronounced "Dexter") and combines a handheld sensor array with a tablet-based user interface and AI diagnostic engine capable of analyzing data, requesting further input, and arriving at a diagnosis.
The regulatory reflex, when presented with a safety concern, is to request further descriptive data from the manufacturers.
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