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Medication use in pregnancy and the pregnancy and lactation labeling rule
Author(s) -
Sahin L,
Nallani SC,
Tassinari MS
Publication year - 2016
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.380
Subject(s) - pregnancy , lactation , medicine , dosing , food and drug administration , medical prescription , obstetrics , clinical pharmacology , drug , gynecology , pharmacology , biology , genetics
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.