真实世界研究(4)
[2]Sherman RE,Anderson SA,Dal Pan GJ,et al.Real-World Evidence-What Is It and What Can It Tell Us?[J].N Engl J Med,2016,375(23):2293-2297.[3]U.S.Food and Drug Administration.Use of Real-World Evidence to Support Regulatory Decisions-Making for Medical Devices: Guidance for Industry and Food and Drug Administration staff[EB/OL].[2017-08-31].http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm513027.pdf.
[4]FDA.Framework for FDA’s Real-World Evidence Program[EB/OL].[2018-11].https://www.fda.gov/media/120060/download.
[5]FDA CDER ......
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