HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Over The Counter 24 May 2022: US OTC Monograph Reform And A 'Faster Moving FDA’ With CHPA’s Barbara Kochanowski and David Spangler

Executive Summary

In this episode, HBW Insight speaks to Barbara Kochanowski and David Spangler of the US Consumer Healthcare Products Association about OTC monograph reform. The OTC monograph program was reimagined as a part of the 2020 CARES act passed in the early stages of the pandemic. While the changes were designed to streamline and modernize the program, results have been slow with the FDA's attention focused on tackling COVID-19. But as the agency hires more staff, Spangler says he expects to see a "faster moving FDA" in the next three years. Spangler and Kochanowski also discuss the efficacy of the monograph reforms and how CHPA has helped educate its members about the changes.

You may also be interested in...



After 10 Years, US FDA ‘Additional Conditions’ Proposed Rule Offers ‘Novel Switch’ Pathway

Publication of "ACNU" proposed rule wasn’t reached in straight line and featured coining another term with more of a regulatory sound, “NSURE,” and detours on explaining where the agency wouldn’t steer OTC drug manufacturing and marketing.

USPSTF Doesn’t See Forest Of VMS Benefits For Trees Of Reducing Cancer, Heart Disease Risks

US Preventative Services Task Force concludes evidence doesn't support  recommending VMS use to prevent cancer or cardiovascular disease. Trade groups and a natural medicine expert say task force's focus is narrow and its recommendation misleading. 

CHPA Adds Pavlick, Miller In Director Posts

Larisa Pavlick joins senior director of quality assurance and technical affairs, and Kirby Miller as director of federal government affairs.

Topics

Latest News
UsernamePublicRestriction

Register

RS152552

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