Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles; Draft Guidance for Industry; Availability
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #292 entitled "Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles." This draft guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) information for Type A medicated articles.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.
Abstract as published in the Federal Register.
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