Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 243.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 243.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 243.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 243.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 243.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Warning: imagejpeg(C:\Inetpub\vhosts\kidney.de\httpdocs\phplern\28674673
.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Ther+Innov+Regul+Sci
2017 ; 51
(3
): 360-371
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
Pediatric Medicine Development: An Overview and Comparison of Regulatory
Processes in the European Union and United States
#MMPMID28674673
Penkov D
; Tomasi P
; Eichler I
; Murphy D
; Yao LP
; Temeck J
Ther Innov Regul Sci
2017[May]; 51
(3
): 360-371
PMID28674673
show ga
Pediatric legislation in the US and the EU is driving pediatric product
development on an international scale. To facilitate harmonization and global
development of pediatric medicines, it is important to understand the legislative
requirements that must be met along with incentives that exist in the US and the
EU to include pediatric patients in therapeutic clinical trials. Although there
are many similarities, differences exist. This review is an effort to enhance
understanding of the pediatric legislation in both regions. It is intended as an
overview to supplement the region-specific legislation and guidance documents
that are available on the websites of the US Food and Drug Administration (FDA)
and the European Medicines Agency (EMA). Despite differences, the goal of the
legislation in both the EU and the US is to incentivize and require timely,
ethical, and sound scientific development of pharmaceutical products for the
pediatric population and to provide information for their safe and effective use.