Novel methods for pregnancy drug safety surveillance in the FDA Sentinel System

Author:

Suarez Elizabeth A.1ORCID,Nguyen Michael2,Zhang Di3,Zhao Yueqin3,Stojanovic Danijela2,Munoz Monica4ORCID,Liedtka Jane5,Anderson Abby6,Liu Wei7ORCID,Dashevsky Inna1,Cole David1,DeLuccia Sandra1,Menzin Talia1,Noble Jennifer1,Maro Judith C.1ORCID

Affiliation:

1. Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School Boston Massachusetts USA

2. Office of Surveillance and Epidemiology Center for Drug Evaluation and Research, US Food and Drug Administration Silver Spring Maryland USA

3. Office of Biostatistics Center for Drug Evaluation and Research, US Food and Drug Administration Silver Spring Maryland USA

4. Division of Pharmacovigilance Center for Drug Evaluation and Research, US Food and Drug Administration Silver Spring Maryland USA

5. Division of Pediatric and Maternal Health Center for Drug and Evaluation Research, US Food and Drug Administration Silver Spring Maryland USA

6. Division of Urology, Obstetrics and Gynecology Center for Drug and Evaluation Research, US Food and Drug Administration Beltsville Maryland USA

7. Division of Epidemiology Center for Drug and Evaluation Research, US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

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