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Zdrowie i gospodarka · 24.06.2024

Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #292 entitled "Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles." This draft guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) information for Type A medicated articles. Type A medicated articles contain new animal drugs and provide for administration of these drugs in animal feed.

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