Medication use in pregnancy and the pregnancy and lactation labeling rule

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 requi...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2016-07, Vol.100 (1), p.23-25
Main Authors: Sahin, L, Nallani, SC, Tassinari, MS
Format: Article
Language:English
Subjects:
Biological Products - administration & dosage
Biological Products - adverse effects
Biological Products - pharmacology
Breast Feeding
Drug Labeling - legislation & jurisprudence
Drug Labeling - standards
Drug-Related Side Effects and Adverse Reactions - prevention & control
Female
Humans
Lactation
Postpartum Period
Pregnancy
Prescription Drugs - administration & dosage
Prescription Drugs - adverse effects
Prescription Drugs - pharmacology
United States
United States Food and Drug Administration
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Summary: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.
ISSN:0009-9236
1532-6535
DOI:10.1002/cpt.380