When can real‐world data generate real‐world evidence?-Reference-Cited by-同舟云学术

When can real‐world data generate real‐world evidence?

Published:2023-10-19 Issue:1 Volume:33 Page:
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiology and Drug

Author:

Rahman Motiur¹,Dal Pan Gerald²,Stein Peter³,Levenson Mark⁴,Kraus Stefanie⁵,Chakravarty Aloka⁶,Rivera Donna R.⁷,Forshee Richard⁸^ORCID,Concato John¹⁹^ORCID

Affiliation:

1. Office of Medical Policy, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

2. Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

3. Office of New Drugs, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

4. Office of Biostatistics, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

5. Office of Regulatory Policy, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

6. Office of the Commissioner US Food and Drug Administration Silver Spring Maryland USA

7. Oncology Center of Excellence US Food and Drug Administration Silver Spring Maryland USA

8. Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

9. Department of Medicine Yale University School of Medicine New Haven Connecticut USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.5715

Reference18 articles.

1. H.R. 34 (14th) Congress: 21st Century Cures Act.2016Accessed January 10 2023.https://www.govtrack.us/congress/bills/114/hr34

2. US Food and Drug Administration (FDA).Framework for FDA's Real‐World Evidence Program.2018Accessed January 10 2023.https://www.fda.gov/media/120060/download

3. US Food and Drug Administration (FDA).CBER and CDER RWE Program. Accessed September 13 2023.https://www.fda.gov/science‐research/real‐world‐evidence/center‐biologics‐evaluation‐and‐research‐center‐drug‐evaluation‐and‐research‐real‐world‐evidence

4. US Food and Drug Administration (FDA).Use of Real‐World Evidence to Support Regulatory Decision‐Making for Medical Devices. Accessed September 06 2023.https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/use‐real‐world‐evidence‐support‐regulatory‐decision‐making‐medical‐devices

5. US Food and Drug Administration (FDA).Examples of Real‐World Evidence (RWE) Used in Medical Device Regulatory Decisions. Accessed September 06 2023.https://www.fda.gov/media/146258/download

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