Perspectives|Articles in Press

Omecamtiv Mecarbil: Decisional Dilemmas and Regulatory Science – Opportunities for Improvement?

      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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      1. US Food and Drug Administration. December 13, 2022: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement. Available from: Accessed January 4, 2023.

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