A systematic assessment of key design and performance characteristics of drug exposure registries requested by the U.S. Food and Drug Administration.
| Author | |
|---|---|
| Abstract |
:
The purpose of the study is to evaluate contributions to postmarket safety assessments and identify potential factors for enhancing implementation and utilization of registries in regulatory decision-making. |
| Year of Publication |
:
2018
|
| Journal |
:
Pharmacoepidemiology and drug safety
|
| Date Published |
:
2018
|
| ISSN Number |
:
1053-8569
|
| URL |
:
http://dx.doi.org/10.1002/pds.4386
|
| DOI |
:
10.1002/pds.4386
|
| Short Title |
:
Pharmacoepidemiol Drug Saf
|
| Download citation |
