federal_register: 2021-26699

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2021-26699 Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Reopening of the Comment Period Notice The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the document entitled "Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance of Industry," published in the Federal Register on September 30, 2021. The Agency is taking this action to allow interested persons additional time to submit comments. 2021-12-10 2021 12 https://www.federalregister.gov/documents/2021/12/10/2021-26699/real-world-data-assessing-electronic-health-records-and-medical-claims-data-to-support-regulatory https://www.govinfo.gov/content/pkg/FR-2021-12-10/pdf/2021-26699.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the document entitled "Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological...

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