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

Framework To Protect NDI Notifications With Master Files Proposed By CHPA, CRN And UNPA

Executive Summary

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.

You may also be interested in...



FDA Sees NDIN Master File Guidance Spurring Compliance, US Industry Looks For Enforcement

Some trade groups couldn’t agree more that spurring NDIN compliance will benefit the supplement industry, but few in industry are convinced the agency will strengthen enforcement of the requirement or across supplement sector generally.

US FDA’s Planned NDIN Guidance On Master Files Not Worth Paper It Would Be Written On – CRN

FDA needs additional funding to support the work of enforcing recommendations from NDIN guidances on separate sections of requirements, particularly for planned guidance on supplement master file framework, CRN head Steve Mister tells Office of Dietary Supplement Programs.

US FDA’s NDI Notification Costs Estimate Doesn’t Add Up For Supplement Industry

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.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS150052

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