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Zdrowie i gospodarka · 01/09/2016

The Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program; Public Workshop

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.

Source: Federal Register — Food and Drug AdministrationOpen original release →