返回 Agenda
Pregnancy and Lactation Labeling Rule: Unique Challenges to Meet Requirements
Session Chair(s)
Leslie Driver, PHARMD
Director, Labeling Strategy and Developement
GlaxoSmithKline, United States
In December 2014, the FDA published “The Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling,” referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR). Drug manufacturers are required to provide specific details pertaining to drug use in pregnancy, lactation, and reproductive risks associated with the drug's use. Companies are encouraged to generate and evaluate data for both pregnancy and lactation, which raise very interesting questions for drug manufacturers and the patient populations that they treat. This session will examine many of these questions. What challenges do manufacturers face when generating, evaluating, and submitting data on the safety of their products for use during pregnancy or lactation? Are current methods of data generation or capture, such as registries, effective, and are there alternatives? In the case of lactation, how do you recruit patients for lactation studies?
Learning Objective : Discuss the challenges of data generation and evaluation to comply with the requirements of the Pregnancy and Lactation Labeling Rule (PLLR), present sponsor experiences with updates to labeling in accordance with PLLR; Review an innovative approach for obtaining robust data from a lactation study
Speaker(s)
P-L-L-R: Not as eXtraordinarily Simple as A-B-C-D
Leslie Driver, PHARMD
GlaxoSmithKline, United States
Director, Labeling Strategy and Developement
Pregnancy and Breastfeeding, Drug Development, and the Public Health
Nina Liang, PHD
Novo Nordisk Inc., United States
Associate Director, Regulatory Affairs
Innovative Approaches for Conducting a Lactation Study
Nicole R Hurst
PPD, United States
Director, Project Management