The US Food and Drug Administration (FDA) is required to make decisions that can at
times be controversial, for a myriad of reasons, on the benefits versus risks for
medical products. This is understandable as science accelerates but with a suboptimal
or more complex evidence generation system. For guidance on some of these decisions,
the FDA occasionally asks an advisory committee to weigh in on particularly vexing
problems. Although not required, and often the issues are boiled down to just a few
key topics, the process helps to provide additional input into yes or no decisions.
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References
US Food and Drug Administration. December 13, 2022: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement. Available from:https://www.fda.gov/advisory-committees/advisory-committee-calendar/december-13-2022-cardiovascular-and-renal-drugs-advisory-committee-meeting-announcement-12132022. Accessed January 4, 2023.
- Cardiac myosin activation with omecamtiv mecarbil in systolic heart failure.N Engl J Med. 2021; 384: 105-116https://doi.org/10.1056/NEJMoa2025797
- Identifying treatments for stage C2 heart failure.JAMA Cardiol. 2022; 7: 34-35https://doi.org/10.1001/jamacardio.2021.4024
- Improving the use of FDA advisory committees.N Engl J Med. 2022; 387: 675-677https://doi.org/10.1056/NEJMp2206492
Article info
Publication history
Published online: January 11, 2023
Accepted:
January 5,
2023
Received:
January 5,
2023
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2023 Elsevier Inc. All rights reserved.
