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

Pay Now For Better Supplement Industry Enforcement, Or Foot Higher Bill Later

This article was originally published in The Tan Sheet

Executive Summary

By considering and addressing potential regulatory changes, the industry more likely can help shape changes and avoid greater regulatory burden such as pre-market review, suggests CRN President Steve Mister. User fees are an “issue that the industry is going to have to start looking at,” he says.

You may also be interested in...



'Real Appetite' For User Fees Among Energy & Commerce Democrats

Committee members' current priorities do not include authorizing user fee programs for the OTC monograph process or supplement GMP inspections, but proposals could get traction. "We think it is a happy medium of getting FDA the resources it needs," says Tiffany Guarascio, minority chief of staff.

In Brief: Acetaminophen Warnings, OTC HSA Bill, Durbin’s Supplement Reg Bill

FDA adds acetaminophen warnings; CHPA suggests 4-aminophenol standard; OTC HSA bill in House; supplement registration bill reintroduced; FSMA user fees still on hold; more scrutiny of energy drinks; and Public Citizen pans OTC Oxytrol.

FDA Revision Of NDI Draft Guidance Starts With Grandfathered List

Trade groups say FDA committed to revisiting issues in the NDI draft guidance including how firms prove ingredients’ grandfathered status, notifications required for ingredients or finished products and data necessary to demonstrate NDI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.

Related Content

Topics

UsernamePublicRestriction

Register

PS106995

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