Priority Zoonotic Animal Drug Designation and Review Process; Draft Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #283 entitled "Priority Zoonotic Animal Drug Designation and Review Process." This draft guidance is intended to assist sponsors pursuing priority zoonotic animal drug (PZAD) designation for a new animal drug. This draft guidance is intended to provide the eligibility criteria for PZAD designation, the process for requesting PZAD designation, and enhancements in the FDA review process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.