Medtech Insight 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


Coalition Expects Higher Personalized Medicine Profile During User Fee Talks

This article was originally published in The Gray Sheet

Executive Summary

Better coordination of device and drug review processes is crucial to the future of personalized medicine and are likely to be an important focus of upcoming user fee negotiations, says the Personalized Medicine Coalition's Amy Miller.

You may also be interested in...

Calls For More FDA Training In Lead Up To User-Fee Negotiations

Device firms will be pushing for more reviewer consistency and to avoid a major increase in fees during upcoming negotiations with FDA to reauthorize the Medical Device User Fee Act. The MDUFA IV reauthorization process starts as Congress is already considering major regulatory reforms and will finish under a new administration in the White House.

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

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.

Senators Circulate Plan For Standalone FDA Diagnostics Center, ‘In Vitro Clinical Test’ Rules

Senators are drafting legislation to create a standalone FDA Center to oversee diagnostics, including IVDs and LDTs, under a framework distinct from current medical device regulations.

Related Content


Latest Headlines
See All



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