EMEA: Concept Paper on the need for the development of a paediatric addendum to the CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

EMEA:
Concept Paper on the need for the development of a paediatric addendum to the CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension. This concept paper discusses the need for regulatory guidance on the clinical development of drugs for PAH in the paediatric population. (22 January 2009)