Accelerated Approval Is Not Conditional Approval-Reference-Cited by-同舟云学术

Accelerated Approval Is Not Conditional Approval

Published:2022-03-01 Issue:3 Volume:8 Page:335
ISSN:2374-2437
Container-title:JAMA Oncology
language:en
Short-container-title:JAMA Oncol

Author:

Mehta Gautam U.¹,de Claro R. Angelo¹²,Pazdur Richard¹²

Affiliation:

1. Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland

2. Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland

Publisher

American Medical Association (AMA)

Subject

Oncology,Cancer Research

Link

https://jamanetwork.com/journals/jamaoncology/articlepdf/2788322/jamaoncology_mehta_2022_vp_210025_1647458317.14809.pdf

Reference9 articles.

1. A 25-year experience of US Food and Drug Administration accelerated approval of malignant hematology and oncology drugs and biologics: a review.;Beaver;JAMA Oncol,2018

2. “Dangling” accelerated approvals in oncology.;Beaver;N Engl J Med,2021

3. Project Orbis: global collaborative review program.;de Claro;Clin Cancer Res,2020

4. Optimizing the use of accelerated approval. Friends of Cancer Research. 2020. Accessed December 13, 2021. https://friendsofcancerresearch.org/sites/default/files/2020-11/Optimizing_the_Use_of_Accelerated_Approval-2020.pdf

5. Food and Drug Administration Safety and Innovation Act, 21 USC §301 (2012). Accessed December 13, 2021. https://www.govinfo.gov/content/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf

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