The Role of Real‐World Evidence in FDA‐Approved New Drug and Biologics License Applications
Author:
Affiliation:
1. Aetion, Inc. New York New York USA
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2474
Reference65 articles.
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5. EMA regulatory science to 2025. Published online 2020 . Accessed August 9 2021.
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