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Business · 23/11/2005

FDA Amends Regulations on Exporting Investigational New Drugs

The Food and Drug Administration (FDA) has updated its rules for exporting unapproved new drug products, including biological medications, to include four new methods for exporting these products, which will simplify the existing requirements and implement changes resulting from the FDA Export Reform and Enhancement Act of 1996.

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

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