federal_register: 2018-15568

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2018-15568 Documenting Electronic Data Files and Statistical Analysis Programs; Draft Guidance for Industry; Availability; Extension of Comment Period Notice The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that published in the Federal Register on May 21, 2018. In that document, FDA requested comments on the draft revised guidance for industry (GFI) #197 entitled "Documenting Electronic Data Files and Statistical Analysis Programs." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. 2018-07-20 2018 7 https://www.federalregister.gov/documents/2018/07/20/2018-15568/documenting-electronic-data-files-and-statistical-analysis-programs-draft-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2018-07-20/pdf/2018-15568.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that published in the Federal Register on May 21, 2018. In that document, FDA requested comments on the draft revised guidance for industry...

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