federal_register: 2015-30937

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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
2015-30937 Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing in Vitro Diagnostic Tests; Public Workshop; Reopening of Comment Period Notice The Food and Drug Administration (FDA) is reopening the comment period for the notice of a public workshop that appeared in the Federal Register of September 9, 2015. In the notice of the public workshop, FDA requested comments on the workshop topics about the proposed standards-based regulatory strategy for next-generation sequencing (NGS) tests that produce results on variation in the human genome. The Agency is taking this action in response to requests to allow interested persons additional time to submit comments. 2015-12-09 2015 12 https://www.federalregister.gov/documents/2015/12/09/2015-30937/standards-based-approach-to-analytical-performance-evaluation-of-next-generation-sequencing-in-vitro https://www.govinfo.gov/content/pkg/FR-2015-12-09/pdf/2015-30937.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is reopening the comment period for the notice of a public workshop that appeared in the Federal Register of September 9, 2015. In the notice of the public workshop, FDA requested comments on the workshop topics...  

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