Pediatric requirements in Europe stymie help for hemophilia

作者:Peyvandi Flora*; Rosendaal Frits R; O'Mahony Brian; Mannucci Pier Mannuccio
来源:Nature Medicine, 2014, 20(2): 117-117.
DOI:10.1038/nm0214-117

摘要

The European Medicines Agency requires that drug developers submit a 'pediatric investigational plan' to ensure that there is adequate information about how children fare on experimental medication for many indications before they go to market. But this requirement places an undue constraint on the makers of new hemophilia drugs and threatens to create an unreasonable delay in access to these therapies among adults with this disorder in the EU.

  • 出版日期2014-2