Hematologic Malignancies and the Food and Drug Administration’s Accelerated Approval Program-Reference-Cited by-同舟云学术

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Hematologic Malignancies and the Food and Drug Administration’s Accelerated Approval Program

Published:2023 Issue:3 Volume:20 Page:
ISSN:1551-8779
Container-title:The Hematologist
language:en
Short-container-title:

Author:

Demoss Patrick¹,Kanapuru Bindu²,Gormley Nicole³

Affiliation:

1. Medical Officer, Division of Hematologic Malignancies II, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

2. Team Lead, Division of Hematologic Malignancies II, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

3. Division Director, Division of Hematologic Malignancies II, Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Publisher

American Society of Hematology

Subject

Modeling and Simulation

Reference14 articles.

1. U.S. Food and Drug Administration. Guidance Document: Expedited Programs for Serious Conditions -- Drugs and Biologics. May 2014. Accessed March 18, 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics.

2. US Food and Drug Administration Accelerated Approval Program for nononcology drug indications between 1992 and 2018;Omae;JAMA Netw Open,2022

3. Accelerated approval of oncology products: the food and drug administration experience;Johnson;J Natl Cancer Inst,2011

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

5. A patent review on FDA-approved antibody-drug conjugates, their linkers and drug payloads;Chia;Chem Med Chem,2022

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