Characteristics of Single Pivotal Trials Supporting Regulatory Approvals of Novel Non‐orphan, Non‐oncology Drugs in the European Union and United States from 2012−2016

by Anne Vinther Morant, Vivien Jagalski, Henrik Tang Vestergaard
Published 2019-07-01

Labeling of Disease-Modifying Therapies for Neurodegenerative Disorders

by Anne Vinther Morant, Vivien Jagalski, Henrik Tang Vestergaard
Published 2019-10-01

US, EU, and Japanese Regulatory Guidelines for Development of Drugs for Treatment of Alzheimer’s Disease: Implications for Global Drug Development

by Anne Vinther Morant, Henrik Tang Vestergaard, Anders Blædel Lassen, Vaidrius Navikas
Published 2020-07-01