Zdrowie i gospodarka · 13/12/2001

International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on “Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)” (VICH GL29); Request for Comments; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (#142) entitled "Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)" (VICH GL29). This draft guidance has been developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance is intended to describe the reporting system for identification of possible adverse events following the use of marketed veterinary medicinal products submitted to the European Union, Japan, and the United States.