Biologics Procedures (SOPPs)

SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA)Effective Date: January 15, 2025SOPP 8401.1: Issuance of and Review of Responses to Information Request Communications to Pending ApplicationsEffective...

Pediatrics and Maternal Health

The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population and improve safety data collection and product labeling for pregnant and lactating...