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's OTC Naloxone Study Is A Starting Point For Other Switches, Not A Roadmap

This article was originally published in The Pink Sheet

Executive Summary

CDER has been studying ideas such as pictograms to communicate instructions on administering opioid-reversal medication, but officials can’t predict when new approaches might help enable FDA to propose regulatory changes in the US switch process.

You may also be interested in...



Cavazzoni Helms US FDA Drug Center With OTC Monograph Reform Starting, Novel Switches Next

Patrizia Cavazzoni, who likely represents a somewhat different leadership style for CDER, distinguished herself while leading the center temporarily during the COVID-19 pandemic.

FDA Plans To Publish 'Novel' OTC Switch NPRM In May 2020

Agency list in HHS Unified Agenda also states intent to publish before end of 2019 an NPRM to add the common cold indication to certain OTC monograph antihistamine ingredients. Nonbinding timelines also included for NPRM on clarifying regarding when studies to evaluate drug uses of products marketed as foods, supplements or cosmetics are subject to IND reviews.

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

RS122838

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