What Does It Take to Transform Real‐World Data Into Real‐World Evidence?-Reference-Cited by-同舟云学术

What Does It Take to Transform Real‐World Data Into Real‐World Evidence?

Published:2019-06-26 Issue:1 Volume:106 Page:10-18
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Ramamoorthy Anuradha¹,Huang Shiew‐Mei¹

Affiliation:

1. Office of Clinical PharmacologyOffice of Translational SciencesCenter for Drug Evaluation and ResearchUS Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1486

Reference34 articles.

1. 21st Century Cures Act.Public Law 114‐255.

2. US Food and Drug Administration.PDUFA reauthorization performance goals and procedures fiscal years 2018 through 2022.

3. The Health Information Technology for Economic and Clinical Health (HITECH) Act (2009).

4. US Food and Drug Administration.Framework for FDA's Real World Evidence Program (2018).

5. Real‐world data, advanced analytics, and the evolution of postmarket drug safety surveillance;Pan G.J.;Clin. Pharmacol. Ther.,2019

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