federal_register: 2018-10722

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2018-10722 Documenting Electronic Data Files and Statistical Analysis Programs; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry (GFI) #197 entitled "Documenting Electronic Data Files and Statistical Analysis Programs." This draft revised guidance is provided to inform sponsors of recommendations for documenting electronic data files and statistical analyses submitted to the Center for Veterinary Medicine (CVM) to support new animal drug applications. 2018-05-21 2018 5 https://www.federalregister.gov/documents/2018/05/21/2018-10722/documenting-electronic-data-files-and-statistical-analysis-programs-draft-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2018-05-21/pdf/2018-10722.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry (GFI) #197 entitled "Documenting Electronic Data Files and Statistical Analysis Programs." This draft revised guidance is provided...  

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