federal_register: 2019-12113

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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
2019-12113 Leveraging Randomized Clinical Trials To Generate Real-World Evidence for Regulatory Purposes; Public Workshop Notice The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes." Convened by Duke University's Robert J. Margolis, MD, Center for Health Policy (Duke Margolis) and supported by a cooperative agreement with FDA, the purpose of the public workshop is to bring the stakeholder community together to explore key considerations for using randomized designs, such as large simple trials or those that incorporate pragmatic elements to generate real- world evidence (RWE). 2019-06-10 2019 6 https://www.federalregister.gov/documents/2019/06/10/2019-12113/leveraging-randomized-clinical-trials-to-generate-real-world-evidence-for-regulatory-purposes-public https://www.govinfo.gov/content/pkg/FR-2019-06-10/pdf/2019-12113.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes." Convened by Duke University's Robert J....  

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