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Business · 03/06/2016Updated: 10/17/2026 · 1 min read

FDA Releases Guidance on Expanded Access to Investigational Drugs for Treatment Use

Summary

The Food and Drug Administration (FDA) has released a guidance document answering frequently asked questions about implementing its expanded access regulations for investigational drugs used for treatment purposes, following a draft released in May 2013.

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

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