Medtech Insight is part of the Business Intelligence Division 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

2016 Will Be A Big Year For Combo Product Reform, FDA Says

This article was originally published in The Gray Sheet

Executive Summary

The agency has already signaled its plan to propose a new statutory pathway for combination products by the end of next year. In the meantime, it's working on a bevy of process changes, guidance documents and rules to enhance premarket and postmarket regulation of combination products in the years ahead. Office of Combination Products officials John Weiner and Thinh Nguyen weigh in.

Advertisement

Related Content

Senate Panel Passes Breakthrough Device, Other Measures; FDA Funding Debated
FDA Guidance Sheds Light On Human Factor Studies For Combo Products
In Case You Missed It: Top 10 "Gray Sheet" Stories In January
Califf Supports Combo Products Pathway At Confirmation Hearing
Senate Bill Aimed At Streamlining Combo Product Regulation
Combo Product Reforms Are A Priority For Next User Fee Round, FDA Officials Say
Podcast: FDA's Califf Talks About Combo Product Reform, Commish Prospects
Human Factors Questions Drive Rise In FDA Inter-Center Consults
Combo Products GMP Guidance Fills In Gaps On Drug-Delivery Device Compliance
FDA Unveils Adverse Event Reporting Rules For Combination Products

Topics

Advertisement
UsernamePublicRestriction

Register

MT034555

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