US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials: A Systematic Review and Meta-analysis.
Sign Up to like & getrecommendations! Published in 2019 at "JAMA network open"
DOI: 10.1001/jamanetworkopen.2019.11111
Abstract: Importance The size of estimated treatment effects on the basis of which the US Food and Drug Administration (FDA) has approved drugs and devices with data from nonrandomized clinical trials (non-RCTs) remains unknown. Objectives To… read more here.
Keywords: drug administration; drug; clinical trials; food drug ... See more keywords
Generating comparative evidence on new drugs and devices after approval
Sign Up to like & getrecommendations! Published in 2020 at "The Lancet"
DOI: 10.1016/s0140-6736(19)33177-0
Abstract: Certain limitations of evidence available on drugs and devices at the time of market approval often persist in the post-marketing period. Often, post-marketing research landscape is fragmented. When regulatory agencies require pharmaceutical and device manufacturers… read more here.
Keywords: marketing; drugs devices; approval; post marketing ... See more keywords
Towards personalized antithrombotic management with drugs and devices across the cardiovascular spectrum.
Sign Up to like & getrecommendations! Published in 2021 at "European heart journal"
DOI: 10.1093/eurheartj/ehab642
Abstract: Intravascular thrombus formation and embolization are among the most frequent events leading to a number of cardiovascular conditions with high morbidity and mortality. The underlying causes are stasis of the circulating blood, genetic and acquired… read more here.
Keywords: management drugs; personalized antithrombotic; towards personalized; devices across ... See more keywords
Progress report on new antiepileptic drugs: A summary of the Fourteenth Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XIV). II. Drugs in more advanced clinical development
Sign Up to like & getrecommendations! Published in 2018 at "Epilepsia"
DOI: 10.1111/epi.14555
Abstract: The Fourteenth Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XIV) took place in Madrid, Spain, on May 13‐16, 2018 and was attended by 168 delegates from 28 countries. The conference provided a forum… read more here.
Keywords: new antiepileptic; report; drugs devices; antiepileptic drugs ... See more keywords