Table of Contents
Introduction to Labeling
Introduction to Labeling (continued)
Labeling: Focal Point for Negotiations
Opportunities for New Data
Postmarketing Safety InformationSpontaneous Reports
“Serious” Adverse Events(at any dose)
Limitations of Case Reports
When are case reports helpful?
Existing Pregnancy Section of Label
Lack of Data
Experience and Feedback
Use only in pregnancy when the benefit outweighs the risk!
Changes are coming….
ICH E2C (continued)
Scientific & Regulatory Decisions
Special Challenges: Pregnancy and Perinatal Exposures