federal_register: 2021-27521

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2021-27521 Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Draft Guidance for Industry; Availability; Extension of Comment Period Notice The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability entitled "Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Draft Guidance for Industry" that appeared in the Federal Register on October 22, 2021. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. 2021-12-21 2021 12 https://www.federalregister.gov/documents/2021/12/21/2021-27521/data-standards-for-drug-and-biological-product-submissions-containing-real-world-data-draft-guidance https://www.govinfo.gov/content/pkg/FR-2021-12-21/pdf/2021-27521.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability entitled "Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Draft Guidance for Industry" that...  

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