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10.3389/fphar.2017.00161 http://scihub22266oqcxt.onion/10.3389/fphar.2017.00161 C5376616!5376616!28420989     free     free     free Deprecated: Implicit conversion from float 227.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 227.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 227.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 227.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 261.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Front+Pharmacol 2017 ; 8 (ä): ä Nephropedia Template TP {{tp|p=28420989|t=2017. FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines |pdf=|usr=}}{{28420989}} gab.com Text FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines JO: Front Pharmacol http://www.kidney.de/pget.php?&tw=1&pmid=28420989 #FOAvip The US Food and Drug Administration (FDA) has four facilitated regulatory pathways (FRPs): Fast Track (FT), Breakthrough Therapy (BTD), Priority Review (PR), and Accelerated Approval (AA). Only PR specifies an expedited review timeline (6 months). We sought to determine to what extent the combination of two or more FRPs influenced development and approval times. We developed a ?metro map? to illustrate FRP elements and their influence on review times. We assessed 125 new active substances (approved January 2013 to December 2015) 74 of which used one or more FRPs. For these 74, development times ranged from 1,458 (BTD + PR + AA) to 3,515 days (PR). PR alone had a median approval time of 242 days. The most common combination was FT + PR (median approval 292 days, n = 21). The fastest approval times were for PR + FT + BTD + AA (145 days) and PR + BTD + AA (166 days). Our findings support the combination of FRPs for shortening development and review times beyond that provided by PR alone. Twit Text FOAVip FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines ????Front Pharmacol http://www.kidney.de/pget.php?&tw=1&pmid=28420989 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=28420989 #FOAvip English Wikipedia <ref>{{Cite pmid|28420989}}</ref> FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines #MMPMID28420989 Liberti L; Bujar M; Breckenridge A; Hoekman J; McAuslane N; Stolk P; Leufkens H Front Pharmacol 2017[]; 8 (ä): ä PMID28420989show ga The US Food and Drug Administration (FDA) has four facilitated regulatory pathways (FRPs): Fast Track (FT), Breakthrough Therapy (BTD), Priority Review (PR), and Accelerated Approval (AA). Only PR specifies an expedited review timeline (6 months). We sought to determine to what extent the combination of two or more FRPs influenced development and approval times. We developed a ?metro map? to illustrate FRP elements and their influence on review times. We assessed 125 new active substances (approved January 2013 to December 2015) 74 of which used one or more FRPs. For these 74, development times ranged from 1,458 (BTD + PR + AA) to 3,515 days (PR). PR alone had a median approval time of 242 days. The most common combination was FT + PR (median approval 292 days, n = 21). The fastest approval times were for PR + FT + BTD + AA (145 days) and PR + BTD + AA (166 days). Our findings support the combination of FRPs for shortening development and review times beyond that provided by PR alone. äFDA Facilitated Regulatory Pathways: Visualizing Their Characteristics(epmc).pdf DeepDyve Pubget Overpricing