US FDA Allows Supplement Firms More Time To Submit NDI Notifications, And For It To Respond
More time for notifications than current deadline of at least 75 days before NDI-containing product is offered for sale in US doesn’t solve problems with FDA’s management of NDI regulation, say trade groups.
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FDA should protect companies which “do the right thing” by submitting new dietary ingredient notifications, CRN's Steve Mister said during FDLI's annual conference.
HELP Committee Chairwoman Patty Murray, and ranking member Richard Burr also include supplement registration requirement in discussion draft for reauthorizing FDA’s user fee programs for prescription, generic and biosimilar drugs and medical devices.
FDA's notice for a May 16 public meeting say it intends to ensure its "regulatory framework is flexible enough to adequately evaluate product safety without unnecessarily restricting innovation." But FDA makes clear adherence with its NDI notification requirement is focus of the spurring improvement in VMS product industry's overall compliance with regulatory framework established by DSHEA.