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

No Authorization For OTC Monograph Reform And User Fees, But Webinar Goes On

This article was originally published in The Rose Sheet

Executive Summary

FDA’s Aug. 23 webinar will update industry stakeholders on progress to modernize its OTC monograph program, but without user fee legislation, new performance goals will not take effect; stakeholders hold out hope a standalone OTC user fee bill could still progress in Congress.

You may also be interested in...



Cosmetic Regulation Update's Link With OTC Drug User Fees Clear At Hearing

Members of the House Health Subcommittee suggest their support for potential OTC monograph reform legislation depends on including provisions that would add substantial details to FDA's oversight of cosmetics manufacturers and a related user fee program.

Second Wind For OTC Monograph User Fee Legislation In House Hearing

House Health Subcommittee's “Modernizing FDA’s Regulation of Over-the-Counter Drugs” hearing Sept. 13 will "examine draft legislation to establish" a user fee program to support FDA's work on evaluating proposals for additions or changes to its nonprescription drug monographs.

Implementing User Fees Should Be Lighter Lift For FDA This Time Around; Bill Heads To White House

The 2017 user fee reauthorization bill contains provisions that should be significantly easier for the agency to implement compared with the 2012 measure. Senate clears clean bill for president's review.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS121147

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