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Geschäft · 30.7.20201 Min. Lesezeit
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Guidance for Industry; Availability
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Zusammenfassung
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products." The guidance describes the circumstances under which FDA generally does not intend to take action regarding required stability studies for unit-dose repackaged solid oral dosage form drug products and appropriate expiration dates under those circumstances. This guidance finalizes the revised draft guidance for industry issued in August 2017.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →