FDA Reverses Position On Fabre-Kramer's Gepirone, Clearing Way For Approval
This article was originally published in The Pink Sheet Daily
Dispute resolution win means focus for antidepressant Travivo (gepirone extended-release) shifts to labeling, post-marketing and manufacturing despite going 2 for 12 in clinical trials.
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Appeals pathway remains unavailable for challenging regulatory advice on drug and biologic product development programs despite objections from industry; sponsors may approach a higher management level to further discuss such advice in meetings established under the user fee programs, final guidance states.
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