Translation of FDA Draft Guidance on Externally Controlled Trials: Enhancing Real-World Evidence in Regulatory Science
Hee-Jin Seo, Yunju Choe, Jeong-Eun Lee, Ju Hwan Kim, Ji Won Kim, Gyeongmin Lim, Woo Hyeon Yoo, YongHyun Cho, Byungsun Yoon, Sungpil Han, Dong Keon Yon and Ju-Young Shin. Pharmacoepidemiology and Risk Management 2025;17:123-35. https://doi.org/10.56142/perm.25.0015
Institutions
- Samsung (South Korea) (KR)
- Kyung Hee University Medical Center (KR)
- Korea Telecom (South Korea) (KR)
- Sungkyunkwan University (KR)
- Catholic University of Korea (KR)
Publication Details
- Journal
- Journal of Pharmacoepidemiology and Risk Management
- Published
- 2025-09-26
- DOI
- https://doi.org/10.56142/perm.25.0015
- Primary Topic
- Geochemistry and Geologic Mapping
- Type
- article
- Field-Weighted Citation Impact
- 0.00