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Zdrowie i gospodarka · 19.05.2003

Draft Guidance for Industry on Dispute Resolution Procedures for Science-based Decisions on Products Regulated by the Center for Veterinary Medicine; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry ([numsign]79) entitled "Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine (CVM)." This draft guidance document describes dispute resolution procedures by which sponsors, applicants, or manufacturers of FDA regulated products for animals may request review of science-based decisions. This draft guidance does not address procedures for handling issues associated with FDA's new initiative to enhance pharmaceutical good manufacturing practices (GMP's).

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