Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

NDI Submissions Fare Better With Early FDA Contact

This article was originally published in The Tan Sheet

Executive Summary

FDA officials encourage firms to work with them before submitting notifications to ensure all necessary information is included, increasing a firm’s chance of success. Most NDI notifications the agency rejects have incomplete information, they say.

You may also be interested in...



FDA NDI Draft Is A Push For Tighter Supplement Regulation – Stakeholders

FDA proposed “a pretty crazy” NDI notification draft guidance, says attorney Wes Siegner, because “they think everything is an NDI.” Other stakeholders acknowledge FDA wants tighter regulation of the industry, but say writing and imposing rules for supplement manufacturing is a two-way street.

FDA Ushers Out Known DMAA, Closes Dietary Ingredient Door

USPlabs says it will reformulate its DMAA supplements, although it “stands by the safety and legality” of the products. FDA says “credible science” shows DMAA is not a botanical, not a dietary ingredient and will not be accepted in an NDI notification.

J&J Consumer Sales Slip Even As Recalled Brands, Seasonal Items Reach Stores

J&J reports worldwide consumer sales dipped 0.6% to $3.6 billion despite retailers buying more upper respiratory and analgesic products to prepare for the cough and cold season. But in key OTC categories the firm is regaining market share it lost when its iconic brands were temporarily not available.

Topics

UsernamePublicRestriction

Register

PS078529

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