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

Combo Product Industry Coalition Proposal Elevates Post-Approval Issues

This article was originally published in The Pink Sheet Daily

Executive Summary

Genzyme, Roche, Guidant are among the firms represented by the Combination Product Coalition to focus on improving post-approval regulatory pathways, such as modifications and cross-labeling for “virtual” combo products.

You may also be interested in...



FDA Combo Product Final Rule Adds "Intended" Use To Primary Mode Of Action Definition

Final rule includes an algorithm for the Office of Combination Products to use if primary mode of action cannot be established.

ICMJE Clinical Trial Registration Criteria Could Exempt High-Risk Medical Devices, Says IoM Report

The Institute’s Board on Health Sciences Policy is preparing a clinical trials registry for fall release.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS059677

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