|
KMID : 1011320190110020062
|
|
Journal of Pharmacoepidemiology and Risk Management
2019 Volume.11 No. 2 p.62 ~ p.71
|
|
|
Establishment of Framework for the Development and Review of Drugs Based on Real-World Data/Real-World Evidence
|
|
Bae Ji-Hwan
Park Han-Heui
Jung Gyu-Won
Sung Hi-Gin
Yang Ji-Young
Hwang Jung-Eun
Yoon Dong-Won
Noh Yun-Ha
Shin Ju-Young
|
|
|
Abstract
|
|
|
In 2016, the United States passed the 21st Century Cures Act to accelerate the FDA’s decision making for new drugs,
biological products and medical devices and support research and development costs. FDA used real world data (RWD)
and real world evidence (RWE) to monitor postmarking safety and adverse events. However, this act places additional
focus on using RWD/RWE to support regulatory decisions such as for adding new indication on already approved
drugs. This paper addresses the status quo and recent trends on how the FDA has applied RWD/RWE to regulatory decision for the purpose of establishing a framework for the use of RWD/RWE in drug development and approval
process.
|
|
|
KEYWORD
|
|
|
Approval process, Real-world Data, Real-world Evidence
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|