FDA “Undercuts” NDI Guidance Opposition With Compliance Cost Estimate – CRN
This article was originally published in The Tan Sheet
Executive Summary
OMB approves FDA’s estimate as the official measure for the supplement industry’s anticipated burden in complying with the NDI notification regulation.
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FDA NDI Notification Cost Estimate Widens Gulf With Stakeholders
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FDA NDI Notification Cost Estimate Widens Gulf With Stakeholders
Stakeholders widely criticize FDA estimates for the industry’s NDI costs – 20 hours to prepare a notification and no capital costs. Industry reps argue the agency’s evolving approach to NDIs will increase costs, and the two sides disagree over the role and cost of research.
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