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

New dietary ingredient notifications

This article was originally published in The Tan Sheet

Executive Summary

FDA should issue a guidance to explain when new dietary ingredient notifications are necessary, as well as the type of information they should include, NNFA says in May 9 letter to the agency. Guidance should establish "whether, and under what conditions, a dietary ingredient that is a component of food (i.e. lycopene in tomatoes) would be exempt" from notification, as well as the quantity, quality of information required to satisfy the "history of use or other evidence of safety" standard. NNFA's comments respond to March 19 FDA notice requesting public feedback on premarket notification process for new dietary ingredients...

You may also be interested in...



Roche Continues To Make The Case For Gantenerumab In Alzheimer’s Disease

The amyloid-targeting drug is years behind Biogen/Eisai’s aducanumab, but its subcutaneous administration and the GRADUATE studies’ design could give Roche’s gantenerumab an advantage.

Brinavess' US Review: EU Postmarket Data Unlikely To Save Troubled AFib Drug

Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug;  FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.

Fledgling Pharma FerGene Makes Quick Debut With Gene Therapy Candidate

FerGene bladder cancer therapy achieved a complete response in more than half of patients in its pivotal trial. The joint venture now looks to commercialization and potential expansion of indications.

Topics

UsernamePublicRestriction

Register

PS094096

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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