FDA | 海南省真实世界数据研究院

NMPA Research Base for Drug and Medical Device Regulatory Science Hainan Institute of Real World Data

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FDA

● International Code of Ethics Review (2020 Edition)

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● 《Considerations for the Use of Real-World Data and Real World Evidence to Support Regulatory Decision-Making for Drug and Biological Products》Guidance for Industry

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● Health Insurance Portability and Accountability Act( HIPAA) of 1996

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● Best Practices for conducting and reporting pharmacoepidemiological safety Studies using Electronic Medical Data - a guide for Industry and FDA Staff

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● Using Real-world Evidence to Support Regulatory Decisions for Medical devices - A guide for FDA and Industry staff

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● Documents submitted to FDA for drugs and biologics using real world data and real world evidence - Guidelines for industry

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● Real world Evidence (RWE) examples - for medical device regulatory decisions

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● Real world evidence procedures

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● The use of electronic medical record data in clinical investigations - an industry guide

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● Public Law 114-255-December 13, 2016-21st Century Cures Act

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● FDA real World data evaluates electronic health records and medical claims data to support regulatory decision guidance for drugs and biologics

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● Interpretation by Yao Chen from Hainan Real Research Institute: THE US FDA issued the

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