title: The new FDA pregnancy labeling requirements for drugs.
abstract: The new US Food and Drug Administration Proposed Rules for pharmaceutical products for the special population of pregnant women were published in May 2008. With these new rules in place, clinicians caring for women who are pregnant may begin to have clearer and more relevant information in the product label to guide clinical decisions regarding drug use during pregnancy.
authors.affiliation: Feinberg Medical School of Northwestern University, 680 N. Lake Shore Drive, Chicago, IL 60611, USA. mcf810@northwestern.edu
authors.forename: Marilynn C
authors.initials: MC
authors.lastname: Frederiksen
mesh_terms: D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D007229:Infant Welfare / Q000331:legislation & jurisprudence*; D007231:Infant, Newborn; D011247:Pregnancy; D037841:Pregnant People; D014481:United States; D014486:United States Food and Drug Administration