Priority Zoonotic Animal Drug Designation and Review Process; Guidance for Industry; Availability

Resumen

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.