Business · 19/09/2025Updated: 10/17/2026 · 1 min read
FDA Announces Draft Guidance on Safety Labeling Changes for Drug and Biological Products
Summary
The FDA is releasing a draft guidance on implementing Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act, which requires labeling changes based on new safety information, and updates the previous guidance issued in 2013.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →