Aker BioMarine Plans US NDI Notification For EPA/DHA Formulated To Pass Blood-Brain Barrier
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.
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Unfounded expectation some firms have for FDA to protect their investments in preparing successful NDI notifications is part of industry’s overall interest in increased regulation of the market, says Steven Tave, Office of Dietary Supplement Programs director.
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.
Rising rates of Alzheimer’s disease and other cognitive conditions fuel demand for brain health supplements among consumers, with more than a third of US consumers saying they would be “very likely” to take them for memory, according to research firm Natural Marketing Institute.