HBW Insight 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

Second Wind For OTC Monograph User Fees Legislation In House Hearing

This article was originally published in The Pink Sheet & The Rose Sheet

Executive Summary

US 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.

You may also be interested in...



Waiting For Congress: Reforming, Paying For FDA OTC Monograph Program

FDA officials emphasize that without legislation from Congress, the OTC monograph program is not changing, and without a user fee program, the agency couldn’t implement changes.

OTC Monograph User Fees Still On The Table, But Not In Legislation

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.

OTC Monograph User Fees Totaling $22m To $34m Floated In Senate Discussion Draft

Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.

Related Content

Topics

UsernamePublicRestriction

Register

OM013057

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