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

FDA Tussles With Combination Products, Fires Up Oncology Center Of Excellence

Executive Summary

FDA officials discuss difficulties dealing with complex combination products, the future of the agency's Centers, and promotion of industry collaboration at DIA meeting.

You may also be interested in...



US FDA May Create Immunology, Neuroscience Centers Of Excellence

Commissioner Gottlieb says new centers would follow template of Oncology Center of Excellence.

US FDA Likely Not 'Significant', Could Be Mostly Spared From Trump's Regulation-Slashing Order

But even though executive order that requires regulatory off sets may only have limited application to FDA, limited, experts warn that it still could prove extremely unwieldly to implement.

FDA's Combo Products Review Transformation Begins

Pilot project sets timelines for lead and consulting centers that will feed into more substantial changes in PDUFA VI.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS120948

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