title: Medication use in pregnancy and the pregnancy and lactation labeling rule.
abstract: On 30 June 2015, the US Food and Drug Administration Pregnancy and Lactation Labeling Rule (PLLR) took effect. This rule sets new and improved standards for the inclusion of information about the use of prescription drugs and biological products during pregnancy and lactation. The new labeling requirements have important implications for clinical pharmacology as there is a subheading that is dedicated to inclusion of clinical pharmacology information that inform dosing during pregnancy and the postpartum period, if available.
authors.affiliation: Division of Pediatric and Maternal Health, Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: L
authors.initials: L
authors.lastname: Sahin
authors.affiliation: Division of Clinical Pharmacology 2, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: S C
authors.initials: SC
authors.lastname: Nallani
authors.affiliation: Division of Pediatric and Maternal Health, Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: M S
authors.initials: MS
authors.lastname: Tassinari
mesh_terms: D001688:Biological Products / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D001942:Breast Feeding; D004348:Drug Labeling / Q000331:legislation & jurisprudence* / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control; D005260:Female; D006801:Humans; D007774:Lactation; D049590:Postpartum Period; D011247:Pregnancy; D055553:Prescription Drugs / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products; D055553:Prescription Drugs