Medtech 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

Combo Product Reforms Are A Priority For Next User Fee Round, FDA Officials Say

This article was originally published in The Gray Sheet

Executive Summary

Top FDA officials, including CDRH Director Jeffrey Shuren and FDA Deputy Commissioner Robert Califf, are sending strong signals that the designation and review processes for combination products are due for a significant reassessment. That should be a priority topic of upcoming user fee negotiations with industry, they say.

You may also be interested in...



Combo Products Won't Get Special Review Pathway At US FDA Anytime Soon

FDA's Jeffrey Shuren and Janet Woodcock tell a Senate committee that the agency is more concerned with implementing combination product provisions from the 21st Century Cures Act than working on a novel review pathway for device/drug combination products.

Reducing Waste In Combo Product Reviews: FDA Goes Lean

The agency disclosed plans to leverage "lean" management techniques, frequently employed in the private sector and by health care organizations, to streamline the process for reviewing new combination products.

Reducing Waste In Combo Product Reviews: FDA Goes Lean

The agency disclosed plans to leverage "lean" management techniques, frequently employed in the private sector and by health care organizations, to streamline the process for reviewing new combination products.

Related Content

Topics

UsernamePublicRestriction

Register

MT033993

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