Pregnancy Adverse Events Could Be Shown Separately Under Labeling Reform
Executive Summary
Pregnancy-related labeling reforms could include displaying birth defect incidence information in a separate section from general adverse events, Center for Drug Evaluation & Research Office of New Drugs Pregnancy Labeling Team Leader Kathleen Uhl, MD, suggested
You may also be interested in...
Pregnancy Registry Guidance Could Stress Collaboration, Tackle HIPAA
FDA is urging companies establishing pregnancy registries to consider a collaborative, multiple-product approach to facilitate more useful data collection
Pregnancy Registry Guidance Could Stress Collaboration, Tackle HIPAA
FDA is urging companies establishing pregnancy registries to consider a collaborative, multiple-product approach to facilitate more useful data collection
CDER Guidance Agenda 2004: Pregnancy, Pediatric Studies Are Priorities
FDA is planning several new guidances to refine recommendations for drug studies in children and pregnant women during 2004, the Center for Drug Evaluation & Research's guidance agenda for the coming year indicates