Review and perspective of FDA transparency initiative
YAO Li-xin
ZHENG Qiang
Abstract：Explore the effect of enhancing transparency on streamlining the patient-centered and productfocused pharmaceutical regulation with public engagement and stakeholders' participation by reviewing the development of FDA transparency initiative.Look into the backgrounds of the proposals,development,and implementation of FDA transparency initiative by analysis of FDA transparency initiatives and literature published.Information disclosure can be used as a low-cost,high-impact regulatory tool to ensure informed decision-making through government transparency,public engagement and multi-party cooperation mechanism.Enhanced transparency should not only be limited to information disclosure.Improved transparency can also promote greater public engagement and interaction with stakeholders in the regulation of medical products to encourage innovation and reduce unnecessary redundancy,and promote public engagement and stakeholders' participation in the patient-centered and productfocused medical product regulation.
Keywords：transparencypublic engagementinformation disclosureinformation sharingmedical product regulation
Publication Date：2018-02-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：12( 255-266 )