Understanding Use of Real‐World Data and Real‐World Evidence to Support Regulatory Decisions on Medical Product Effectiveness

Author:

Mahendraratnam Nirosha1,Mercon Kerra1,Gill Mira1,Benzing Laura1,McClellan Mark B.1

Affiliation:

1. Duke Margolis Center for Health Policy Duke University Washington District of Columbia USA

Funder

AbbVie

Amgen

Eli Lilly and Company

Pfizer

Genentech

GlaxoSmithKline

Merck

Novartis

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference19 articles.

1. US Food and Drug Administration.Framework For FDA’s Real‐World Evidence Program. Department of Health & Human Services (2018).

2. U.S. Food and Drug Administration.PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 through 2022. Department of Health and Human Services (2017).

3. 21st Century Cures Act. 42 USC 201 (2016).

4. Mahendraratnam N.et al.Adding real‐world evidence to a totality of evidence approach for evaluating marketed product effectiveness. Duke Margolis Center for Health Policy (2019).

5. U.S. Food and Drug Administration.FDA's Sentinel Initiative. Department of Health and Human Services (2019).

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