Use of Real-world Data for New Drug Applications and Line Extensions

Author:

Bolislis Winona R.,Fay Myriam,Kühler Thomas C.

Publisher

Elsevier BV

Subject

Pharmacology (medical),Pharmacology

Reference60 articles.

1. FDA's historical use of "real world evidence";Belson,2018

2. Real World Evidence to Guide the Approval and Use of New Treatments;Galson,2016

3. Multidimensional evidence generation and FDA regulatory decision making: defining and using "real-world" data;Jarow;JAMA,2017

4. Real-world data for regulatory decision making: challenges and possible solutions for Europe;Cave;Clin Pharmacol Ther,2019

5. Real-world evidence,2019

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