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
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| Journal | :
Pharmacoepidemiology and drug safety
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| Date Published | :
2018
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| ISSN Number | :
1053-8569
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| URL | :
http://dx.doi.org/10.1002/pds.4386
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| DOI | :
10.1002/pds.4386
|
| Short Title | :
Pharmacoepidemiol Drug Saf
|
| Download citation |