Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #292 entitled "Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles." This draft guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) information for Type A medicated articles.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.
Abstract as published in the Federal Register.
See the structure of SPEQ’s reviewed analysis
Explorer members can open three bounded, human-reviewed previews each month. Full relationships, analysis, and implementation implications remain protected.
Sign in free to preview →The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →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.