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

por Morant, Anne Vinther, Jagalski, Vivien, Vestergaard, Henrik Tang
Publicado 2019

Labeling of Disease-Modifying Therapies for Neurodegenerative Disorders

por Morant, Anne Vinther, Jagalski, Vivien, Vestergaard, Henrik Tang
Publicado 2019

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

por Morant, Anne Vinther, Vestergaard, Henrik Tang, Lassen, Anders Blædel, Navikas, Vaidrius
Publicado 2020

New Drug and Biologics Approvals in 2019: A Systematic Analysis of Patient Experience Data in FDA Drug Approval Packages and Product Labels

por Schultz-Knudsen, Katrine, Sabaliauskaite, Ugne, Hellsten, Johan, Lassen, Anders Blaedel, Morant, Anne Vinther
Publicado 2020