Assessing congenital malformation risk from medications used in pregnancy: The contribution of NBDPS in pregnancy labeling of prescription drug products

Author:

Tassinari Melissa S.1,Sahin Leyla1,Yao Lynne P.1

Affiliation:

1. Division of Pediatric and Maternal Health; Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration; Silver Spring Maryland

Publisher

Wiley

Subject

Developmental Biology,Embryology,General Medicine,Pediatrics, Perinatology, and Child Health

Reference12 articles.

1. Maternal treatment with opioid analgesics and risk for birth defects;Broussard;Am J Obstet Gynecol,2011

2. FDA Drug Safety Communications 2015 http://www.fda.gov/Drugs/DrugSafety/ucm429117.htm

3. Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products;Federal Register;Federal Register,2006

4. Content and format of labeling for human prescription drug and biological products: requirements for pregnancy and lactation labeling;Federal Register;Fed Regist,2014

5. Acetaminophen use and risk of birth defects;Feldkamp;Obstet Gynecol,2010

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