Wednesday, May 18, 2022 | The Latest Research, Commentary, And News From Health Affairs
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In the article, the authors pay particular attention to the ten drugs approved despite
a negative advisory committee vote.
They find that the number of new approved drugs receiving advisory committee review decreased from 59 percent in 2011 to only 6 percent in 2021.
The authors also note inconsistencies in the wording of FDA questions posed to the advisory committees. Daval and authors propose that the FDA provide clear and specific criteria for how it chooses to subject new drugs to external scrutiny.
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