Use of Real‐World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018

Use of Real‐World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018–2019

Published:2021-11-16 Issue:1 Volume:111 Page:310-320
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Eskola Sini Marika¹²,Leufkens Hubertus Gerardus Maria¹,Bate Andrew³⁴⁵,De Bruin Marie Louise¹,Gardarsdottir Helga¹⁶⁷

Affiliation:

1. Utrecht Centre for Pharmaceutical Policy and Regulation Division of Pharmacoepidemiology and Clinical Pharmacology Faculty of Science Utrecht University Utrecht The Netherlands

2. European Federation of Pharmaceutical Industries and Associations Brussels Belgium

3. Global Safety GSK Brentford Middlesex UK

4. Department of Non‑Communicable Disease Epidemiology London School of Hygiene and Tropical Medicine London UK

5. Department of Medicine NYU Grossman School of Medicine New York NY USA

6. Department of Clinical Pharmacy University Medical Center Utrecht The Netherlands

7. Department of Pharmaceutical Sciences School of Health Sciences University of Iceland Reykjavík Iceland

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2462

Reference44 articles.

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3. EMA Regulatory Science to 2025.Strategic reflection (2020). Accessed April 11 2020.

4. U.S. Food and Drug Administration.Framework for FDA's real‐world evidence program (2018). Accessed March 1 2019.

5. U.S. Food and Drug Administration.Submitting documents using real‐world data and real‐world evidence to FDA for drugs and biologics guidance for industry DRAFT Guidance (2019). Accessed March 13 2020.

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