Articles tagged with “pregnancy-risk-summary”

PLLR for Biologics: Drafting Clear Pregnancy Risk Summaries

Learn how the FDA's PLLR replaced old pregnancy categories. This guide explains how to draft clear pregnancy risk summaries for complex biologics with limited d

50 min read

11/23/2025

pllr pregnancy risk summary biologics fda labeling drug safety regulatory affairs monoclonal antibodies medical writing