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Priority Zoonotic Animal Drug Designation and Review Process; 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 #283 entitled "Priority Zoonotic Animal Drug Designation and Review Process." This guidance is intended to assist sponsors pursuing Priority Zoonotic Animal Drug (PZAD) designation for a new animal drug. This guidance is intended to provide the eligibility criteria for PZAD designation, the process for requesting PZAD designation, and enhancements in the FDA review process for PZADs.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →