Using a Benefit–Risk Analysis Approach to Capture Regulatory Decision Making: Renal Cell Carcinoma-Reference-Cited by-同舟云学术

Using a Benefit–Risk Analysis Approach to Capture Regulatory Decision Making: Renal Cell Carcinoma

Published:2019-09-27 Issue:3 Volume:107 Page:495-506
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Raju G. K.¹,Gurumurthi Karthik¹,Domike Reuben¹²,Singh Harpreet³,Weinstock Chana³,Kluetz Paul³,Pazdur Richard³,Woodcock Janet³

Affiliation:

1. Light Pharma, Inc. Cambridge Massachusetts USA

2. Manufacturing Engineering Brigham Young University Provo Utah USA

3. Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Funder

U.S. Food and Drug Administration

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1589

Reference36 articles.

1. US Food and Drug Administration.Benefit–risk assessment in drug regulatory decision‐making (March2018). Accessed March 13 2019.

2. US Food and Drug Administration.Structured approach to benefit‐risk assessment in drug regulatory decision‐making. Draft PDUFA V implementation plan—February 2013. Fiscal years 2013–2017.https://www.fda.gov/media/84831/download(2013). Accessed August 22 2019.

3. National Center for Health Statistics.Health: Unites States 2010: With Special Feature on Death and Dying. Hyattsville MD (2011). Accessed August 27 2019.

4. The PCAST Report: Impact and Implications for the Pharmaceutical Industry

5. The PCAST Report on Pharmaceutical Innovation: Implications for the FDA

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