Scientific Publications by FDA Staff

Clin Pharmacol Ther 2016 Jul;100(1):23-5

Medication use in pregnancy and the pregnancy and lactation labeling rule.

Sahin L, Nallani SC, Tassinari MS

INTRODUCTION: On June 30, 2015, the FDA 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.