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10.1080/17512433.2020.1821650 http://scihub22266oqcxt.onion/10.1080/17512433.2020.1821650 32909843!ä!32909843 Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=32909843&cmd=llinks): Failed to open stream: HTTP request failed! 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Remdesivir emergency approvals: a comparison of the U S , Japanese, and EU systems |pdf=|usr=}}{{32909843}} gab.com Text Remdesivir emergency approvals: a comparison of the U S , Japanese, and EU systems JO: Expert Rev Clin Pharmacol http://www.kidney.de/pget.php?&tw=1&pmid=32909843 #FOAvip INTRODUCTION: There were no formal regulatory approvals for antivirals for the COVID-19 pandemic as of June 2020. AREAS COVERED: We compare the first regulatory approvals for remdesivir, through emergency pathways available to three of the main regulators in the world, the U.S., Japan, and the EU. We look at the data supporting the decisions and how authorities exchanged information and collaborated to speed up approvals. Based only on topline data available as of 29 April 2020, regulators granted approvals to remdesivir based on very limited but robust data and waiting for more safety and efficacy data. This included the Emergency Use Authorization in the U.S. on 1 May, the Special Approval for Emergency in Japan on 7 May, and Compassionate Use (3 April) followed by a Conditional Marketing Authorization in Europe (Opinion 25th June, Decision (3 July)). EXPERT OPINION: While the regulatory approvals were clearly based on evidence, regulators used agile methods to speed up approval, and make the first antiviral with reliable data available to patients in their constituencies in a very short time frame. More data and wider patient access are still necessary for this product, and more treatments are needed for patients affected by COVID-19. Twit Text FOAVip Remdesivir emergency approvals: a comparison of the U S , Japanese, and EU systems ????Expert Rev Clin Pharmacol http://www.kidney.de/pget.php?&tw=1&pmid=32909843 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=32909843 #FOAvip English Wikipedia <ref>{{Cite pmid|32909843}}</ref> Remdesivir emergency approvals: a comparison of the U S , Japanese, and EU systems #MMPMID32909843 Saint-Raymond A; Sato J; Kishioka Y; Teixeira T; Hasslboeck C; Kweder SL Expert Rev Clin Pharmacol 2020[Oct]; 13 (10): 1095-1101 PMID32909843show ga INTRODUCTION: There were no formal regulatory approvals for antivirals for the COVID-19 pandemic as of June 2020. AREAS COVERED: We compare the first regulatory approvals for remdesivir, through emergency pathways available to three of the main regulators in the world, the U.S., Japan, and the EU. We look at the data supporting the decisions and how authorities exchanged information and collaborated to speed up approvals. Based only on topline data available as of 29 April 2020, regulators granted approvals to remdesivir based on very limited but robust data and waiting for more safety and efficacy data. This included the Emergency Use Authorization in the U.S. on 1 May, the Special Approval for Emergency in Japan on 7 May, and Compassionate Use (3 April) followed by a Conditional Marketing Authorization in Europe (Opinion 25th June, Decision (3 July)). EXPERT OPINION: While the regulatory approvals were clearly based on evidence, regulators used agile methods to speed up approval, and make the first antiviral with reliable data available to patients in their constituencies in a very short time frame. More data and wider patient access are still necessary for this product, and more treatments are needed for patients affected by COVID-19. |*Drug Approval[MESH] |Adenosine Monophosphate/*analogs & derivatives/therapeutic use[MESH] |Alanine/*analogs & derivatives/therapeutic use[MESH] |Antiviral Agents/*therapeutic use[MESH] |Betacoronavirus[MESH] |COVID-19[MESH] |COVID-19 Drug Treatment[MESH] |Compassionate Use Trials[MESH] |Coronavirus Infections/*drug therapy[MESH] |Emergency Medical Services[MESH] |European Union[MESH] |Humans[MESH] |Japan[MESH] |Pandemics[MESH] |Pneumonia, Viral/*drug therapy[MESH] |SARS-CoV-2[MESH]Remdesivir emergency approvals: a comparison of the U S , Japanese, an(epmc).pdf DeepDyve Pubget Overpricing