Articles tagged with “fda-labeling”

The FDA Boxed Warning: Regulatory Strategy & Negotiation

Explore the regulatory process for negotiating an FDA boxed warning on drug labeling, from initial NDA review to post-market Safety Labeling Changes (SLCs).

35 min read

11/23/2025

boxed warning fda labeling regulatory affairs drug safety pharmacovigilance safety labeling change (slc)section 505(o)(4)

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