Case Study on the Use of Real-World Evidence in a Feasibility Assessment of a Randomized Controlled Trial Design to Support the Fulfillment of Pediatric Requirements with the FDA and EMA.
Introduction: Regulatory agencies may require industry sponsors of new drugs or biologics to conduct clinical trials that assess the benefits versus the risks of these new medicines in pediatric patients as a means of facilitating their development and availability for children when there is a medic...
| Publicado en: | Therapeutic Innovation & Regulatory Science Vol. 60; no. 5; pp. 1490 - 1500 |
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| Autores principales: | , , , , , , , , , |
| Formato: | case study tables/charts Journal Article |
| Publicado: |
Springer Nature
Sep2026
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| Acceso en línea: | Ver este registro en EBSCOhost |