Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway-Reference-Cited by-同舟云学术

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Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway

Published:2024-06-04 Issue:1 Volume:17 Page:
ISSN:2052-3211
Container-title:Journal of Pharmaceutical Policy and Practice
language:en
Short-container-title:Journal of Pharmaceutical Policy and Practice

Author:

Shahzad Mahnum¹,Naci Huseyin²,Esselen Katharine M.³,Dottino Joseph A.³,Wagner Anita K.¹

Affiliation:

1. Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA

2. Department of Health Policy, London School of Economics and Political Science, London, UK

3. Beth Israel Deaconess Medical Center, Boston, MA, USA

Funder

Harvard Medical School

American Cancer Society

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/20523211.2024.2351003

Reference56 articles.

1. The FDA Struggle to Withdraw Makena

2. Revisiting FDA Approval of Aducanumab

3. Approvals of drugs with uncertain benefit–risk profiles in Europe

4. Conditional approval of medicines by the EMA

5. A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics

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