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Zdrowie i gospodarka · 19.07.2005

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 a guidance for industry ( 79) entitled "Guidance for Industry: Dispute Resolution Procedures for Science- Based Decisions on Products Regulated by the Center for Veterinary Medicine (CVM)." This 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 guidance does not address procedures for handling issues associated with FDA's new initiative to enhance pharmaceutical good manufacturing practices (GMPs).

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