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10.1016/j.clinthera.2020.06.014 http://scihub22266oqcxt.onion/10.1016/j.clinthera.2020.06.014 32651020!7321022!32651020     free     free     free Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Clin+Ther 2020 ; 42 (8): 1444-1450 Nephropedia Template TP {{tp|p=32651020|t=2020. COVID-19: Regulatory Landscape of Medicinal and Medical Device Products for Human Use |pdf=|usr=}}{{32651020}} gab.com Text COVID-19: Regulatory Landscape of Medicinal and Medical Device Products for Human Use JO: Clin Ther http://www.kidney.de/pget.php?&tw=1&pmid=32651020 #FOAvip Against the backdrop of the COVID pandemic, the scientific and medical communities are working with all deliberate speed with state-of-the-art technologies to develop diagnostic and therapeutic products that can identify, treat, and prevent infection with SARS-CoV-2. These activities may only be legally conducted with the necessary statutes and regulations in place to facilitate the timely development, manufacturing, evaluation, and distribution of products that meet quality standards. The present regulatory landscape for medicinal and medical products for human use has been shaped by nearly 12 decades of statutory history that followed in reaction to disasters and tragedies. Five distinct, closely woven threads of statutory history have led to the regulatory infrastructure we have in place: (1) standardized processes for routine development of medicinal and medical device products for human use; (2) processes for expedited development to shorten time frames and expand patient populations; (3) mechanisms of Expanded Access to make medicinal products available to patients prior to approval of the US Food and Drug Administration; (4) Emergency Use Authorization during public health emergencies; and (5) the development of pathways for bringing generic drugs and biosimilar biologics to market. These mechanisms are being brought to bear to facilitate the defeat of infection with SARS-CoV-2. Twit Text FOAVip COVID-19: Regulatory Landscape of Medicinal and Medical Device Products for Human Use ????Clin Ther http://www.kidney.de/pget.php?&tw=1&pmid=32651020 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=32651020 #FOAvip English Wikipedia <ref>{{Cite pmid|32651020}}</ref> COVID-19: Regulatory Landscape of Medicinal and Medical Device Products for Human Use #MMPMID32651020 Beninger P Clin Ther 2020[Aug]; 42 (8): 1444-1450 PMID32651020show ga Against the backdrop of the COVID pandemic, the scientific and medical communities are working with all deliberate speed with state-of-the-art technologies to develop diagnostic and therapeutic products that can identify, treat, and prevent infection with SARS-CoV-2. These activities may only be legally conducted with the necessary statutes and regulations in place to facilitate the timely development, manufacturing, evaluation, and distribution of products that meet quality standards. The present regulatory landscape for medicinal and medical products for human use has been shaped by nearly 12 decades of statutory history that followed in reaction to disasters and tragedies. Five distinct, closely woven threads of statutory history have led to the regulatory infrastructure we have in place: (1) standardized processes for routine development of medicinal and medical device products for human use; (2) processes for expedited development to shorten time frames and expand patient populations; (3) mechanisms of Expanded Access to make medicinal products available to patients prior to approval of the US Food and Drug Administration; (4) Emergency Use Authorization during public health emergencies; and (5) the development of pathways for bringing generic drugs and biosimilar biologics to market. These mechanisms are being brought to bear to facilitate the defeat of infection with SARS-CoV-2. |*Medical Device Legislation[MESH] |Antiviral Agents/therapeutic use[MESH] |Betacoronavirus/immunology[MESH] |COVID-19[MESH] |COVID-19 Drug Treatment[MESH] |COVID-19 Testing[MESH] |Clinical Laboratory Techniques[MESH] |Coronavirus Infections/*diagnosis/drug therapy/epidemiology/prevention & control/*therapy[MESH] |Drug Approval/*legislation & jurisprudence[MESH] |Drug Development/legislation & jurisprudence[MESH] |Humans[MESH] |Pandemics/prevention & control[MESH] |Pneumonia, Viral/*diagnosis/epidemiology/prevention & control/*therapy[MESH] |SARS-CoV-2[MESH] |United States[MESH]COVID-19: Regulatory Landscape of Medicinal and Medical Device Product(epmc).pdf DeepDyve Pubget Overpricing