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  • EMA Adopts Addendum to CHMP Guideline on PAH Products

    The European Medicines Agency (EMA) adopted on 7 February the Paediatric addendum to the CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension (PAH). The addendum includes guidance on how to develop PAH products for pediatric populations, including points of distinction to be made between idiopathic PAH and associated PAH, ethical issues, considerations for trial selection, feasible trial endpoints, t...