title: Assessing congenital malformation risk from medications used in pregnancy: The contribution of NBDPS in pregnancy labeling of prescription drug products.
abstract: BACKGROUND
  Obtaining human pregnancy data to inform product labeling is important for drug and biological products.
  
  
  METHODS
  Collection and analyses of safety data on their use during pregnancy is usually performed after approval.
  
  
  RESULTS
  The Centers for Disease Control National Birth Defects Prevention Study has provided important data on the relationship between drug use in pregnancy and birth defects.
  
  
  CONCLUSIONS
  The Pregnancy and Lactation Labeling Rule will set new and improved standards for the inclusion of information about the use of prescription drugs and biological products during pregnancy; the National Birth Defects Prevention Study, along with other data sources, will be critical for providing safety data to inform product labeling.
authors.affiliation: Division of Pediatric and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Melissa S
authors.initials: MS
authors.lastname: Tassinari
authors.affiliation: Division of Pediatric and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Leyla
authors.initials: L
authors.lastname: Sahin
authors.affiliation: Division of Pediatric and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Lynne P
authors.initials: LP
authors.lastname: Yao
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control; D002487:Centers for Disease Control and Prevention, U.S.; D016208:Databases, Factual; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D005260:Female; D006801:Humans; D007774:Lactation / Q000187:drug effects*; D011159:Population Surveillance; D011247:Pregnancy; D055553:Prescription Drugs / Q000009:adverse effects*; D012307:Risk Factors; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D055553:Prescription Drugs
keywords: FDA; NBDPS; pregnancy labeling