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'Extensive Proof-of-Concept Studies in TNF-Alpha Antagonists might be Responsible for A Delay of Patient Access in Pediatric Rheumatology'

Authors :
Peter Schlattmann
Jürgen Brunner
Nalân Utku
Glyn Steventon
Birka Lehmann
Source :
Biomedical Journal of Scientific & Technical Research. 39
Publication Year :
2021
Publisher :
Biomedical Research Network, LLC, 2021.

Abstract

In order to improve the route to market for approved pediatric therapeutics, the current Pediatric Regulation in the EU and the Food and Drug Administration (FDA) Amendments Act (FDAAA) were both adopted in 2007..

Details

ISSN :
25741241
Volume :
39
Database :
OpenAIRE
Journal :
Biomedical Journal of Scientific & Technical Research
Accession number :
edsair.doi...........a0db217983493a45914049e4f6582901
Full Text :
https://doi.org/10.26717/bjstr.2021.39.006244