Orphan Drug Designations and Orphan Subsets

11/09/2022 9 min Temporada 3 Episodio 1
Orphan Drug Designations and Orphan Subsets

Listen "Orphan Drug Designations and Orphan Subsets"

Episode Synopsis

FDA’s Orphan Drug Designation provides incentives to encourage the development of treatments for rare diseases. Listen as Mara Holinger, SVP of Regulatory Affairs at Veristat and members of the regulatory team shed light on ODD classification and the strategic use of subsets in study design.