federal_register: 2015-21583

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2015-21583 Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #227 entitled "Two- Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections." The guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) data submissions to the Center of Veterinary Medicine (CVM) to support approval of a new animal drug or abbreviated new animal drug. 2015-09-01 2015 9 https://www.federalregister.gov/documents/2015/09/01/2015-21583/two-phased-chemistry-manufacturing-and-controls-technical-sections-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2015-09-01/pdf/2015-21583.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #227 entitled "Two- Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections." The guidance provides recommendations to sponsors...  

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