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US FDA To Sponsors: No Dice On Appealing Advice Through Dispute Resolution

 
• By Sue Sutter

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.

FDA entrance sign 2016

Drug and biologic product sponsors may request higher level review of US FDA advice on development programs, just not through the agency's formal dispute resolution process.

In a final guidance announced in the Federal Register Nov. 6, FDA stands by its view, staked out in a September 2105 draft guidance, that advice conveyed to sponsors in...

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