Business · 19/10/2009Updated: 10/17/2026 · 1 min read

FDA Releases Guidance on Labeling for Human Prescription Drugs and Biologicals

Summary

The FDA has finalized a guidance document to help industry and review staff determine the established pharmacologic class for human prescription drugs and biological products, which will be used in the Highlights of Prescribing Information.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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