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

FDA OTC Switch Guidance Omits Some Turns As Approval Roadmap, CHPA Says

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

Executive Summary

In its comment on draft guidance, OTC industry trade group urges US FDA to issue final guidance on "Innovative Approaches For Nonprescription Drug Products" in addition to a rule the agency has indicated would soon follow.  CHPA expects that identifying information away not within a Drug Facts label that will be considered in an FDA evaluation would be determined on a case-by-case basis, with a switch NDA sponsor and the agency agreeing to terms of approval during a proposal development and review.

You may also be interested in...



In Consumers' Self-Care Drive, OTC Firms See Platform For Boosting Industry Trust

Influencing consumers with facts about health care topics frequently littered with inaccurate advice from non-expert social media sources requires having trust, say consumer health business executives from Bayer, J&J, Sanofi and Taisho Pharmaceutical at the Consumer Healthcare Products Association executive conference. "From a trust perspective, I think that health care is a deeply personal and emotional issue. ... it is definitely important to be fact-based," said Katie Devine, J&J's consumer self-care business global president.

With High Profile At FDA, Gottlieb Headed Ambitious Consumer Health Initiatives

Scott Gottlieb claimed higher profile than most previous FDA commissioners with frequent Twitter posts and by including his remarks in many agency communications to industries and consumers. In his nearly two years in post, he also had more central role in FDA initiatives in areas such as keeping unsafe products labeled as supplements off the market and explaining why hemp and CBD are available and supplements even though FDA considers the products noncompliant as dietary ingredients.

Innovation In OTC Switches Takes Multimedia Approach In US FDA Draft Guidance

Sponsors can point consumers to video displays, website information and mobile apps to help them choose products that have been switched from Rx to OTC. Draft guidance on innovative switch applications to be followed by rule-making in near future.

Related Content

Topics

UsernamePublicRestriction

Register

LL1131561

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