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

US Senate Passes First Monograph Reform Bill After House Passed Three

Executive Summary

Senate's Over-the-Counter Monograph Safety, Innovation, and Reform Act goes next for consideration by House, which has had a bill by the same title on its floor for a vote since it was passed by Energy and Commerce Committee in late June.

You may also be interested in...



US Health Market In 2019: Unfinished Business Leaves Lasting Impression

Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.

Chinese OTC Patch Manufacturer Feels Pain Of US FDA Import Alert, Warning

FDA places Kangdi Medical Devices on import alert and warns it on GMP violations initially noted in 2016. FDA also notes in warning that the Chinese company’s two pain-relief patches are noncompliant with the external analgesics TFM.

Stability Key For US FDA, But Changes Needed For Consumer Health Are Clear

Some stakeholders in regulated industries are concerned that without a history as a public agency executive, Stephen Hahn could have an unpredictable tenure as  FDA commissioner. Still, consumer health industry trade groups note regulatory topics crucial to the industry's growth and consumer safety should be clear.

Related Content

Topics

UsernamePublicRestriction

Register

RS149510

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