federal_register: 2014-27523
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014-27523 | Developing and Using Precision Therapies in the “Omics” Era: Generating and Interpreting Evidence for Rare Subsets; Public Workshop | Notice | The Food and Drug Administration (FDA or the Agency) is announcing a public workshop entitled "Developing and Using Precision Therapies in the `Omics' Era: Generating and Interpreting Evidence for Rare Subsets." This public workshop is being cosponsored with the Center for Translational and Regulatory Sciences at the University of Virginia (UVA). The goals of this public workshop are to facilitate discussion on current scientific approaches using rare subsets during drug development programs and to further seek input from multiple stakeholders on approaches to obtain evidence that inform the regulatory evaluation of therapeutic products in rare subsets of patients identified through in-vitro diagnostic testing when specific, controlled trials are not feasible. | 2014-11-21 | 2014 | 11 | https://www.federalregister.gov/documents/2014/11/21/2014-27523/developing-and-using-precision-therapies-in-the-omics-era-generating-and-interpreting-evidence-for | https://www.govinfo.gov/content/pkg/FR-2014-11-21/pdf/2014-27523.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or the Agency) is announcing a public workshop entitled "Developing and Using Precision Therapies in the `Omics' Era: Generating and Interpreting Evidence for Rare Subsets." This public workshop is being... |