Approval Timelines for Advanced Therapeutics in Inflammatory Bowel Disease: A Comparison Between the European Medicines Agency and the Food and Drug Administration
Inflamm Bowel Dis. 2023 Aug 17:izad168.
doi: 10.1093/ibd/izad168.
Online ahead of print.
1 Department of Gastroenterology and Hepatology, University Medical Center Ljubljana, University of Ljubljana, Ljubljana, Slovenia.
2 Alimentiv Inc, London, ON, Canada.
3 Department of Community Health Sciences, University of Calgary, Calgary, AB, Canada.
4 Division of Gastroenterology & Hepatology, Department of Medicine, University of Calgary, Calgary, AB, Canada.
5 Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
6 Independent statistical consultant, London, ON, Canada.
7 Division of Pediatric Gastroenterology and Hepatology, Department of Pediatrics, Children's Hospital Western Ontario, Western University, London, ON, Canada.
8 Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
9 Department of Epidemiology and Biostatistics, Western University, London, ON, Canada.
10 Division of Gastroenterology, Department of Medicine, Western University, London, ON, Canada.