Pink Sheet 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

Common Combo Product Designation Mistakes To Be Outlined In Upcoming Guidance

Executive Summary

US FDA's Office of Combination Products hopes Q&A guidance will help lower high refusal rate on requests for designation.

You may also be interested in...



US FDA's Generics Program Reaches 'Steady State' Milestone

OGD Director Uhl says program is now in balance between the number of submissions and agency review actions.

Combo-Product Sponsors Could More Easily Get Device Designation At US FDA

Commissioner Gottlieb says upcoming guidance could help nudge products into preferred device realm if they are on cusp between drug or device jurisdictional designation.

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help sponsors understand Office of Combination Product’s thinking, and that a formalized process envision in the new draft guidance could make this dialogue more difficult.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS124115

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