federal_register: 2014-28713

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2014-28713 Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Draft Guidance for Industry; Extension of Comment Period Notice The Food and Drug Administration (FDA) is extending the comment period for a notice of availability of draft guidance for industry (GFI #227) entitled "Two-Phased Chemistry, Manufacturing, and Controls Technical Sections" that appeared in the Federal Register of October 20, 2014. In that notice, FDA made available for comment the draft guidance, which provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) data submissions. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. 2014-12-09 2014 12 https://www.federalregister.gov/documents/2014/12/09/2014-28713/two-phased-chemistry-manufacturing-and-controls-technical-sections-draft-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2014-12-09/pdf/2014-28713.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is extending the comment period for a notice of availability of draft guidance for industry (GFI #227) entitled "Two-Phased Chemistry, Manufacturing, and Controls Technical Sections" that appeared in the Federal...

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