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Business · 09/04/2002Updated: 10/17/2026 · 1 min read

FDA Releases Draft Guidance on IND Exemptions for Marketed Cancer Drugs and Biological Products

Summary

The Food and Drug Administration (FDA) has released a draft guidance document outlining exemptions from investigational new drug (IND) application requirements for studies of marketed cancer drugs or biological products, aiming to reduce the burden on investigators and regulators.

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

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