| PHUSE US |
2020 |
An Update on CDISC-SEND Data Submissions to FDA |
Jesse Anderson, Christopher Bartlett, Jennifer Feldmann, Valerie Gross, Alejandro Mankin, Qingying Lu, Kathryn Matto |
source presentation source |
7 |
| PHUSE US |
2019 |
FDA View: Update on Study Data Submission |
Ethan Chen |
source presentation source |
6 |
| PHUSE EU |
2018 |
Modernising the New Drug Regulatory Program at the FDA/CDER [presentation] |
|
source |
55 |
| PHUSE US |
2018 |
FDA View: Technical Rejection Criteria for Study Data |
Ethan Chen |
source presentation source |
4 |
| PHUSE US |
2018 |
The Changing Landscape of Data Quality at CDER: an Overview of the Core DataFitness Assessment |
Crystal Allard, Michelle Dieter |
source presentation source |
8 |