Regulatory and Industry Perspective on the Model Master File Framework for Locally Acting Drug Products

Author/s:Walenga, Ross; Alam, Khondoker; Clarke, James F.; De Backer, J.; Friden, Markus; Hamadeh, Abdullah; Mowli, Jay; Sonti, Sujatha; Spires, Jessica; Tan, Ming-Liang; Musuamba, Flora T; Tsakalozou, Eleftheria

Date:05/01/2025

Journal:Pharmaceutical Research

DOI:10.1007/s11095-025-03823-5