Pink Sheet 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

A Tale Of Two Expectations: NDI Notification Estimate And Guidance

Regulatory Burden Notice Prompts Doubt While Hope Endures For Revised Draft

This article was originally published in The Tan Sheet

Executive Summary

FDA’s estimates for supplement manufacturers’ burden for submitting NDI notifications continue to miss the mark widely, say trade group executives. The agency would be more on target, they say, with a revised draft guidance on NDI notifications expected to reflect stakeholders’ suggestions.

You may also be interested in...



Ingredients Missing From Potential Pre-DSHEA List Could Be Class Action Bullseyes

A potential official list of pre-DSHEA dietary ingredients must allow adding more that are substantiated later, or it could spur class action litigation targeting ingredients not on the list. FDA announces topics for Oct. 3 public meeting on processes and policy for an authorized list of "old" ingredients.

FDA Revision Of NDI Draft Guidance Starts With Grandfathered List

Trade groups say FDA committed to revisiting issues in the NDI draft guidance including how firms prove ingredients’ grandfathered status, notifications required for ingredients or finished products and data necessary to demonstrate NDI safety. The agency’s decision followed a meeting between industry allies Sens. Hatch and Harkin and FDA Commissioner Hamburg.

Allowing States To Ban Abortion Services Increases Calls For Making Birth Control Available OTC

Supreme Court’s six conservative justices say Constitution doesn’t guarantee a woman’s right to abortion services nor prohibit states from regulating or banning the services. Dissenting liberal members decry decision as erasing women’s constitutional rights.

Topics

Latest News
UsernamePublicRestriction

Register

PS107526

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