Use of Real-World Evidence to Support FDA Approval of Oncology Drugs-Reference-Cited by-同舟云学术

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Use of Real-World Evidence to Support FDA Approval of Oncology Drugs

Published:2020-10 Issue:10 Volume:23 Page:1358-1365
ISSN:1098-3015
Container-title:Value in Health
language:en
Short-container-title:Value in Health

Author:

Feinberg Bruce A.,Gajra Ajeet,Zettler Marjorie E.,Phillips Todd D.,Phillips Eli G.,Kish Jonathan K.

Publisher

Elsevier BV

Subject

Public Health, Environmental and Occupational Health,Health Policy

Reference20 articles.

1. BAVENCIO (avelumab) [prescribing information],2017

2. Multi-discipline Review: Application Number: 208700Orig1s000,2018

3. LUTATHERA [prescribing information],2018

4. Medical Review(S): Application Number: 125557Orig1s000,2014

5. BLINCYTO (blinatumomab) for Minimal Residual Disease Positive (MRD+) B-cell Precursor Acute Lymphoblastic Leukemia (ALL),2018

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3. Real‐world evidence to support regulatory submissions: A landscape review and assessment of use cases;Clinical and Translational Science;2024-08

4. A New Criterion for Determining a Cutoff Value Based on the Biases of Incidence Proportions in the Presence of Non-differential Outcome Misclassifications;Epidemiology;2024-07-05

5. When Will Real-World Data Fulfill Its Promise to Provide Timely Insights in Oncology?;JCO Clinical Cancer Informatics;2024-06

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