US FDA To Sponsors: No Dice On Appealing Advice Through Dispute Resolution
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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PTC Therapeutics appears to be hoping that CDER Director Woodcock will do for ataluren what she did for Sarepta's exon-skipping Duchenne muscular dystrophy treatment Exondys 51 since dispute resolution request would first go to Office of New Drugs, where Woodcock is acting director.
FDA has twice refused to file PTC Therapeutics' NDA for the Duchenne muscular dystrophy treatment because of 'clearly and convincingly negative' pivotal trials and questionable post hoc analyses; sponsor argues ataluren should be afforded the same consideration and flexibility given to Sarepta's DMD drug eteplirsen, which received a controversial accelerated approval.
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