Framework To Protect NDI Notifications With Master Files Proposed By CHPA, CRN And UNPA
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.
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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.
Aker BioMarine seeks supplement firms to use its EPA/DHA innovation bound by lysophosphatidylcholine to enable the fatty acids to pass through the blood-brain and blood-retinal barriers and boost of eye and brain health benefits. It will submit an NDI notificaion in the US during 2022.
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.