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Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016.

作者信息

Brown Beatrice L, Mitra-Majumdar Mayookha, Darrow Jonathan J, Moneer Osman, Pham Catherine, Avorn Jerry, Kesselheim Aaron S

机构信息

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

Yale School of Medicine, New Haven, Connecticut.

出版信息

JAMA Intern Med. 2022 Oct 3;182(11):1223-6. doi: 10.1001/jamainternmed.2022.4226.

Abstract
摘要

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本文引用的文献

1
Trends in the Quality of Evidence Supporting FDA Drug Approvals: Results from a Literature Review.
J Health Polit Policy Law. 2022 Dec 1;47(6):649-672. doi: 10.1215/03616878-10041093.
2
New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence.
Drug Saf. 2022 Apr;45(4):305-318. doi: 10.1007/s40264-022-01152-9. Epub 2022 Feb 19.
3
US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.
Clin Trials. 2021 Aug;18(4):488-499. doi: 10.1177/17407745211005044. Epub 2021 Apr 16.
5
The Food and Drug Administration Amendments Act and postmarketing commitments.
JAMA. 2013 Jul 10;310(2):202-4. doi: 10.1001/jama.2013.7900.

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