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federal_register: E9-5650

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E9-5650 Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry <greek-i>197 entitled "Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files." The purpose of this draft guidance is to simplify the preparation and evaluation of submissions in support of new animal drug applications by providing a uniform system for documenting statistical analysis programs and data files. 2009-03-16 2009 3 https://www.federalregister.gov/documents/2009/03/16/E9-5650/draft-guidance-for-industry-on-documenting-statistical-analysis-programs-and-data-files-availability https://www.govinfo.gov/content/pkg/FR-2009-03-16/pdf/E9-5650.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry <greek-i>197 entitled "Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files." The purpose of this draft guidance...

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