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" ... "Orexigen conducted a large cardiovascular outcomes trial in order to file for approval, with the study planned to continue after approval to serve a postmarketing regulatory requirement for additional risk exclusion. We observed an unexpected result in the interim analysis. We filed patent applications based on the results in order to preserve the potential for additional intellectual property. During the course of the study, the FDA informed us it had determined that the Light Study would not serve as the postmarketing requirement for Contrave; a new trial would be required. At this point, the company decided to continue with the patent prosecution. The second cardiovascular outcomes trial is expected to start later this year, and we look forward to the results of that study which are anticipated by 2022. ... "
" ... Hauser cites the Riata/Riata ST recall as a failure of postmarketing surveillance. He’s critical of St. Jude on the lack of clinical data guiding current recommendations of how to deal with externalized leads. Detection of this problem and assessment of its clinical significance has been difficult and recommendations have been made based on educated consensus, rather than ongoing prospective clinical performance data. ... "
" ... Since continuation of the Light Study was not a postmarketing requirement (PMR), and the majority of patients are no longer on blinded study drug, Orexigen had long advocated shutting down the study in December 2014, corresponding with the time of the 50% interim analysis, and focusing resources on new studies to further evaluate the therapeutic profile of Contrave. ... "
" ... The FDA said it was requiring J&J to perform five postmarketing studies with canaglifozin, including a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; and a bone safety study. ... "