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

OTC Umbrella Branding Soaked By Regulatory Storm In Draft Guidance – CHPA

This article was originally published in The Pink Sheet Daily

Executive Summary

The trade group recommends FDA write a separate proprietary name guidance for OTC drugs. FDA’s draft guidance also renders useless OTC manufacturers’ expertise in conducting tests to determine whether consumers safely self-select nonprescription drugs based on labeling, CHPA says in comments.

You may also be interested in...



Draft Guidance On Developing Drug Names Calls For Simulation Studies

FDA’s draft guidance on developing proprietary drug names recommends steps to evaluate a proposed name, including testing names with health care professionals. The draft notes that OTC “brand name extensions have posed problems when the same root proprietary name is used for multiple products.”

Drug Proprietary Name Selection: Draft Guidance Calls For Simulation Studies

FDA draft guidance on developing proprietary drug names recommends series of steps for sponsors to evaluate a proposed name; safety review includes testing name with healthcare professionals.

Umbrella Brand Debate Lives On At FDA Naming Workshop

Critics of drug labels' effectiveness say reducing errors in the use of OTC drugs depends largely on a change manufacturers oppose - reining in umbrella branding

Topics

Related Companies

UsernamePublicRestriction

Register

AG032824

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