federal_register: 2016-21046

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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
2016-21046 The Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program; Public Workshop Notice The Food and Drug Administration (FDA) is announcing a public workshop entitled "The Sentinel Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program." The purpose of the workshop is to describe the Sentinel Initiative and PRISM program, illustrate how PRISM is used by FDA for regulatory responsibilities (including how it has been integrated into FDA's regulatory review process and case examples), and discuss the future direction of PRISM in terms of expansion and further integration into the regulatory review process. 2016-09-01 2016 9 https://www.federalregister.gov/documents/2016/09/01/2016-21046/the-sentinel-post-licensure-rapid-immunization-safety-monitoring-program-public-workshop https://www.govinfo.gov/content/pkg/FR-2016-09-01/pdf/2016-21046.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing a public workshop entitled "The Sentinel Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program." The purpose of the workshop is to describe the Sentinel Initiative and PRISM program,...  

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