International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Guidance for Industry on “Target Animal Safety for Veterinary Pharmaceutical Products,” VICH GL43; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry ( 185) entitled "Target Animal Safety for Veterinary Pharmaceutical Products," VICH GL43. The purpose of this harmonized guidance is to provide recommendations regarding target animal safety (TAS) evaluation for regulatory submission of an Investigational Veterinary Pharmaceutical Product (IVPP), which is appropriate for determining the safety of an IVPP in the target animal. The guidance includes recommendations on including identification of target organs, where possible, and confirmation of margin of safety, using the minimum number of animals appropriate for the studies.