US FDA Keeps Estimate For NDI Notification Burden At Level Supplement Industry Doubts
FDA again sets expected costs at level supplement industry repeatedly has said drastically underestimates spending on preparing and submitting NDI notifications. But FDA says developing scientific evidence to support a notification is separate from submitting the information to the agency.
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FDA estimate “simply perpetuates the agency’s previous misunderstanding of the burden that NDI notifications impose,” says CRN CEO Steve Mister. FDA says its estimate is for costs of submitting information, not for studies to generate the information.
Consumer Healthcare Products Association, Council for Responsible Nutrition and United Natural Products Alliance model proposed NDI-master file framework on US Drug Master File FDA has accepted for decades. System would not be administered by FDA, but the agency’s support is critical for helping manufacturers protect their investments in research for information supporting NDI notifications.
Like FDA's draft guidance on NDI notifications and its previous estimates for compliance with that regulation and the GMP final rule, the agency's latest estimate on manufacturers' annual burdens associated with GMP recordkeeping prompts industry questions.