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

Combination Product Designations At US FDA Need Faster Appeals, Petition Says

Executive Summary

No sponsor is named in the citizen petition, but it was filed on behalf of an applicant that has had a designation-decision appeal "under consideration" for 18 months and counting.

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.

Combo Product Consultations At US FDA May Suffer As They Become Formalized

Brad Thompson says that phone calls used in current informal process help sponsors understand Office of Combination Product’s thinking, and that a formalized process envision in the new draft guidance could make this dialogue more difficult.

Combo Product Review Pilot At US FDA Will Offer All Applications Intercenter Consults

Agency will collect qualitative and quantitative data to evaluate pilot's success and refine form usability and format, reviewer assignment and general timeline expectations.

Related Content

Topics

UsernamePublicRestriction

Register

MT104580

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