To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on pub...

por Kühler, Thomas Christian, Bujar, Magda, McAuslane, Neil, Liberti, Lawrence
Publicado 2019

Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice

por Rodier, Céline, Bujar, Magda, McAuslane, Neil, Patel, Prisha, Liberti, Lawrence
Publicado 2020

Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory Authorities

por McAuslane, Neil, Bujar, Magda, Sithole, Tariro, Ngum, Nancy, Owusu-Asante, Mercy, Walker, Stuart
Publicado 2023

FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines

por Liberti, Lawrence, Bujar, Magda, Breckenridge, Alasdair, Hoekman, Jarno, McAuslane, Neil, Stolk, Pieter, Leufkens, Hubert
Publicado 2017

A decade comparison of regulatory decision patterns for oncology products to all other non‐oncology products among Swissmedic, European Medicines Agency, and US Food and Drug Admin...

por Rohr, Ulrich‐P., Iovino, Mario, Rudofsky, Leonie, Li, Qiyu, Juritz, Stephanie, Gircys, Arunas, Wildner, Oliver, Bujar, Magda, Bolte, Claus, Dalla Torre di Sanguinetto, Simon, Wolfer, Anita
Publicado 2023