Editorial
doi: 10.7326/M21-3393.
Epub 2021 Sep 21.
Moving the U.S. Food and Drug Administration Forward
Affiliations
- PMID: 34543586
- PMCID: PMC11745233
- DOI: 10.7326/M21-3393
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Editorial
Moving the U.S. Food and Drug Administration Forward
Ann Intern Med.
2021 Nov.
No abstract available
Comment on
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U.S. Food and Drug Administration Reasoning in Approval Decisions When Efficacy Evidence Is Borderline, 2013-2018.Ann Intern Med. 2021 Nov;174(11):1603-1611. doi: 10.7326/M21-2918. Epub 2021 Sep 21. Ann Intern Med. 2021. PMID: 34543584
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References
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- U.S. Food and Drug Administration. What We Do. Updated 28 March 2018. Accessed at www.fda.gov/about-fda/what-we-do on 15 August 2021.
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- U.S. Food and Drug Administration. Food and Drug Administration Modernization Act (FDAMA) of 1997. Updated 29 March 2018. Accessed at www.fda.gov/regulatory-information/selected-amendments-fdc-act/food-and-... on 15 August 2021.
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- U.S. Food and Drug Administration. FDA grants accelerated approval for Alzheimer’s drug. 7 June 2021. Accessed at www.fda.gov/news-events/press-announcements/fda-grants-accelerated-appro... on 16 August 2021.
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- U.S. Food and Drug Administration. Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) meeting minutes. 6 November 2020. Accessed at www.fda.gov/media/145691/download on 16 August >2021.
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- Massie T. BLA 761178 statistical review: aducanumab in Alzheimer’s. Accessed at https://collaboration.fda.gov/pradgevcxis7 on 30 August 2021.
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