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Business · 15/09/2003Updated: 10/17/2026 · 1 min read

FDA Releases Guidance on Exemptions for Studies of Lawfully Marketed Cancer Treatments

Summary

The Food and Drug Administration (FDA) has announced the availability of a new guidance document that clarifies its policy on exempting studies of marketed cancer treatments from investigational new drug application (IND) requirements, aiming to reduce unnecessary exemptions.

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

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