Real World-Evidence for Regulatory Use Decision Aid: An Interactive Tool To Inform Clinical Development and Regulatory Strategies

por Burns, Leah, Kalesnik-Orszulak, Robert, Spring, Rick, Zeegers, Fabienne, Rutstein, Mark, Hukkelhoven, Mathias, Wruck, Lisa, O’Donnell, John
Publicado 2022

Real-world evidence for regulatory decision-making: updated guidance from around the world

por Burns, Leah, Le Roux, Nadege, Kalesnik-Orszulak, Robert, Christian, Jennifer, Dudinak, Jennifer, Rockhold, Frank, Khozin, Sean, O’Donnell, John
Publicado 2023