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

Codeine Concerns Cough Up FDA's OTC Monograph Problems

This article was originally published in The Pink Sheet

Executive Summary

Pew Charitable Trusts joins CHPA, medical groups in urging Congress to authorize moving the US monograph system to an administrative process and to authorize a monograph user fee program.

You may also be interested in...



Opioids: FDA Eyes Better Prescriber Education, But Academics Urge Promotion Crackdown

US agency is convening two-day workshop on federal efforts to support healthcare provider education about pain management and safe use of the drugs; two University of Washington researchers say agency needs to exercise stricter oversight of opioid marketing and promotion.

OTC Monograph Reform, User Fee Legislation Coming 'Any Day' – CHPA

Imminent OTC monograph reform legislation signals an agreement between industry and FDA on details of a proposal, which also includes a potential user fee program. CHPA also is hopeful for legislation restoring direct OTC drug purchases with pre-tax savings accounts.

OTC Monograph User Fees Inspire Wary Support From Industry

Executives from OTC drug manufacturers list numerous doubts about the equity and effectiveness of a potential program that would impose user fees on firms that make or market monograph drugs, the vast majority of nonprescription pharmaceutical products.

Related Content

Topics

UsernamePublicRestriction

Register

GB150348

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