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FDA advisory committee meeting outcomes

Nature Reviews Drug Discovery volume 11, pages 513–514 (2012)Cite this article

Subjects

FDA advisory committee meetings are high-stakes interactions, with many years of effort, millions of dollars of investment, potential regulatory approval and billions of dollars in potential sales for a new drug riding on the outcome. However, despite the fact that sponsors recognize the crucial nature of these meetings and are familiar with the processes, we have found limitations in the quantitative understanding of their outcomes. In this article, we have analysed publicly available data on FDA advisory committee meetings with the aim of helping to address these limitations. We investigated several important issues, including the total number of meetings by type and therapeutic area, the frequency with which new product applications are subjected to advisory committee meetings, consistency between the advisory committee votes and FDA approval decisions, and the duration between an advisory committee meeting and the final FDA approval date for a product.

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Figure 1: Characteristics of FDA advisory committee meetings between 2001 and 2010.
Figure 2: Analysis of a subset of 63 FDA advisory committee meetings that included votes for or against the approval of a new drug between 2001 and 2010.

Author information

Authors and Affiliations

  1. Jeffrey F. Smith and Seth A. Townsend are at McKinsey & Company, 600 Campus Drive, Florham Park, New Jersey 07932, USA.,

    Jeffrey F. Smith & Seth A. Townsend

  2. Navjot Singh is at McKinsey & Company, 55 East 52nd Street, New York, New York 10022, USA.,

    Navjot Singh

  3. Philip Ma is at McKinsey & Company, 3075A Hansen Way, Palo Alto, California 94304, USA.,

    Philip Ma

Authors
  1. Jeffrey F. Smith
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  2. Seth A. Townsend
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  3. Navjot Singh
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  4. Philip Ma
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Corresponding author

Correspondence to Philip Ma.

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Competing interests

The authors declare no competing financial interests.

Supplementary information

Supplementary Box S1

Background information and data sources (PDF 131 kb)

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Smith, J., Townsend, S., Singh, N. et al. FDA advisory committee meeting outcomes. Nat Rev Drug Discov 11, 513–514 (2012). https://doi.org/10.1038/nrd3747

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