HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

US FDA Allows Supplement Firms More Time To Submit NDI Notifications, And For It To Respond

Executive Summary

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.

You may also be interested in...



Protection For NDIs Bigger Concern In US Than Giving More Time For Notifications, CRN Contends

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.

NDI Notification Guidance Deadline Included In Senate Draft Bill For FDA User Fee Programs

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.

NDI Notifications Take Center Stage In FDA's Evaluation Of DSHEA

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.

Topics

Latest News
UsernamePublicRestriction

Register

RS152538

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel