BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 21.06.2007

International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Revised Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms (VICH GL30); Request for Comments; Availability

The Food and Drug Administration (FDA) is announcing the availability for comments of a revised draft guidance for industry ( 143) entitled "Revised Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms" (VICH GL30). This revised draft guidance, which updates a draft guidance on the same topic for which a notice of availability was published in the Federal Register of February 6, 2002 (the 2002 guidance), has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document describes the specific data elements to be used for the submission and exchange of spontaneous adverse event reports (AERs) between marketing authorization holders (MAHs) and regulatory authorities (RAs).

Source: Federal Register — Food and Drug AdministrationOpen original release →