Research and Drug Development

  1. Showing 2 results for:
  2. Research and Drug Development
All SubjectsResearch and Drug Development

Rare Pediatric Priority Review Voucher

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsPaediatric MedicineMarketing AuthorisationOrphan MedicineRegulatory AdviceRare Paediatric Priority Voucher

This program grants a voucher for priority review from the US Food and Drug Administration (FDA), which aim to render a decision within 6 months (in contrast to 10 for a standard review). The developed drug for which the voucher is awarded must be intended for a rare disease or condition and that primarily affect individuals from 0 to 18 years. The voucher can be utilized for any other drug development program.

View this resource Bookmark this resource

European Network of Paediatric Research at the European Medicines Agency

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsOrphan DrugEarly Access SupportPaediatric MedicineEuropean Network of Paediatric Research

The European Network of Paediatric Research at the European Medicines Agency (Enpr- EMA) is a network of research networks, investigators and centres with recognised expertise in performing clinical studies in children. Enpr-EMA enables networking and collaboration with members from within and outside the European Union (EU), including academia and the pharmaceutical industry

View this resource Bookmark this resource