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

All Roads For OTC Policy Improvements Lead To User Fees, FDA Suggests

This article was originally published in The Pink Sheet

Executive Summary

During update on user fee discussions with industry to support FDA's OTC monograph program work, CDER officials say "industry and public would suffer" absent new fees.

You may also be interested in...



FDA Rule Marks Consumer Antibac Soaps A Possible Endangered Species

FDA’s rule “clarifies the mission” for manufacturers of consumer antibacterial soaps, which have a year to demonstrate that they are safe and effective or risk losing the entire OTC drug category.

OTC Monograph User Fees: FDA-Industry Talks Move From Basics To Details

CDER officials and industry met in July to discuss "the ground rules governing the OTC monograph user fee." CHPA CEO Scott Melville cautions: "No one is going to rush into an agreement that we're going to have to live with for decades."

'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.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS123104

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